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510(k) Data Aggregation

    K Number
    K243861
    Device Name
    butterflyBVM
    Manufacturer
    Compact Medical, Inc.
    Date Cleared
    2025-04-25

    (130 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Product Code :

    BTM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The butterflyBVM™ when used in transport and non-clinical emergency settings (e.g., EMS, non-hospital) is a single-use resuscitator that may be manipulated to provide pulmonary resuscitation of patients including adults, adolescents, children, infants, and neonates. The butterflyBVM™ when used in professional healthcare facilities (e.g., hospitals) is a single-use resuscitator that may be manipulated to provide pulmonary resuscitation of patients including adults, adolescents, children, and infants.
    Device Description
    The butterflyBVM™ is a three-in-one bag-valve-mask capable of resuscitating adults, adolescents, children, infants, and neonates. The maximum tidal volumes (Vt) delivered by the butterflyBVM™ can be set via the tidal volume dial, as needed, to ranges that are generally appropriate for the size of patient receiving care. The butterflyBVM™ also has an adjustable peak inspiratory pressure (PIP) dial to help prevent barotrauma. The tidal volume and PIP are selected by aligning the dials to the Vt/PIP indicator. Patient-facing accessories such as masks, laryngeal mask airways, endotracheal tubes, end-tidal CO2 samplers, and the like can be connected to the patient connection port. Exhalation accessories such as bio filters and PEEP valves can be connected to the exhalation port. Supplemental oxygen can be added via the oxygen inlet port. The device is operated by manually squeezing the side arms together with either one or two hands. A cover is provided over the PIP dial to provide instruction to the user via images and words to first set the tidal volume for the procedure based on the assessment of the patient.
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    K Number
    K221841
    Device Name
    EOlife®
    Manufacturer
    ARCHEON
    Date Cleared
    2023-03-18

    (267 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Product Code :

    BTM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EOlife is intended for use with emergency manual resuscitation devices to measure ventilatory flows and display visual guide on the insufflated volume, and ventilation frequency to ensure adequate ventilation of adult cardiopulmonary arrest patient during cardiopulmonary resuscitation (CPR) performed by healthcare professionals.
    Device Description
    EOlife is a medical device dedicated to healthcare professionals to help them providing manual ventilation during cardiopulmonary resuscitation (CPR). EOlife is intended to be connected to any standard manual resuscitator for adults including a bag and a mask or endotracheal tube (ET tube) and supraglottic airway (SGA) device and to be used during manual ventilation of an adult cardiopulmonary arrest patient. EOlife is a portable device composed of an electronic control unit including an embedded software, a removable and rechargeable battery pack and of a single use flow sensor: FlowSense. EOlife does not present direct contact with the patient. Only the ventilation air flow is in contact with the internal part of FlowSense (indirect contact with the patient). During manual ventilation, EOlife measures the ventilation parameters (insufflated volumes, tidal volumes, ventilation frequencies, ) and gives real-time feedback to the user about the quality of the ventilation provided to the patient compared to the 2020 AHA (American Heart Association) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Part 3: Adult Basic and Advanced Life Support. The aim is to help the user ventilate according to the recommended frequencies (10 cycles per minute) and volumes (6-8 ml/kg of ideal body weight).
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    K Number
    K212905
    Device Name
    Sotair Device
    Manufacturer
    Safe BVM Corporation
    Date Cleared
    2022-08-18

    (339 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Product Code :

    BTM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sotair™ device is intended for use with a manual resuscitator with air-tight connections, in non-breathing patients that require flow controlled ventilation using ambient air or a supplemental oxygen source. The Sotair device is a single use, disposable device added to a manual resuscitator and can be used for in-hospital, emergency, and transport care. The adult Sotair device comprises a flow-limiting valve that limits the inspiratory flow enabling providers to ventilate approximately 55 liters-per-minute (LPM). The flow-limiting valve is intended to minimize gastric inflation during manual ventilation. The Sotair device can be disabled by removing the manual resuscitator to its conventional operation. The Sotair device is intended for adult use only.
    Device Description
    The Sotair™ device is a universal safety accessory device that is compatible with all manual resuscitators and airway interfaces that have standard ISO 5356-1:2015 15/22 mm connections. The Sotair device's flow-limiting function has been tested with the following bag resuscitators: [List of compatible resuscitators provided in the document]. The Sotair device is not compatible with manual resuscitators that have a built-in flow limiting device. The Sotair device uses a flapper valve with a blade design to limit the flow rate.
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    K Number
    K210288
    Device Name
    Disposable Manual Resuscitator
    Manufacturer
    Xiamen Compower Medical Tech. Co., Ltd.
    Date Cleared
    2021-08-26

    (205 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Product Code :

    BTM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single patient use manual resuscitator for use in hospital, transport, emergency, and post-hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10 kg Child: less than or equal to 23 kg Adult: greater than 23 kg
    Device Description
    Disposable manual resuscitator is disposable, medical device, which temporarily augment ventilation in patients during ventilatory insufficiency or ventilator failure. Disposable manual resuscitator uses a duck-bill valve in the non-rebreathing valve assembly, attaches the non-rebreathing valve directly onto the resuscitation bag and includes an oxygen enrichment (reservoir) system. Disposable manual resuscitator may be used in hospital, transport, emergency, and post hospital care to temporary ventilate a patient. Disposable manual resuscitator is for single patient used. It comprises of mask, oxygen tube, reservoir bag and resuscitator bag. It is used to temporary ventilate a patient for the given body mass ranges of: Infant - Less than or equal to 10 kg Child - less than or equal to 23 kg Adult - Greater than 23 kg.
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    K Number
    K181583
    Device Name
    Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
    Manufacturer
    Flexicare Medical Limited
    Date Cleared
    2018-12-07

    (175 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Product Code :

    BTM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Flexicare's Adult Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments. Flexicare's Pediatric Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of infants and children with a body weight of 22lbs to 66lbs (10-30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments. Flexicare's Infant Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight of up to 22lbs (10kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.
    Device Description
    Flexicare's Single Use Resuscitator Bags are Single Use devices For manual ventilation of a patient by trained operators in emergency/critical situations where short term ventilation is demanded by the patient's medical condition (e.g. inadequate or no breathing). Manual squeezing of the resuscitator bag forces air or air /O2 mixture into the patient's lungs via a face mask or pre-positioned airway tube with a 15mm male connection. A reservoir bag is present at the distal end of the device which fills with supplementary O2 (if using). This can be squeezed into the resuscitator for administration if required. Flexicare's Single Use Resuscitator Bags feature a one-way duck bill valve at the patient end to deliver fresh gas to the patient whilst preventing ingress of exhaled air and potential rebreathing. A one-way valve is also present at the distal end of the device, ensuring that upon squeezing the Resuscitator bag air only travels toward the patient, and upon release of a squeezed bag fresh ambient air with/without supplementary O2 is drawn in. Flexicare's Single Use Resuscitator Bags incorporate a pressure relief valve. This valve limits the pressure within the resuscitator and patient lungs to 60cmHzO (Adult) or 40cmHzO (Adult, Pediatric, Infant). One variant of Flexicare's Adult Single Use Resuscitator Bags does not feature a pressure relief valve. Flexicare's Single Use Resuscitator Bags are comprised of disposable components including a compression bag, valves, tubing and connectors. The Single Use Resuscitator Bags are intended for Adult. Pediatric and Infant patients, are supplied non sterile and are for use by CPR-trained personnel only within a hospital and/ pre-hospital environments.
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    K Number
    K170663
    Device Name
    Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
    Manufacturer
    Foremount Enterprise Co., Ltd.
    Date Cleared
    2018-05-11

    (431 days)

    Product Code
    BTM, BYE, CAP
    Regulation Number
    868.5915
    Why did this record match?
    Product Code :

    BTM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10Kg. Child: less than or equal to 23 Kg. Adult: greater than 23 Kg This manual resuscitator may be supplied with a single patient use positive end expiratory pressure (PEEP) valve and / or disposable Airway Pressure Manometer. The PEEP Valve is a single patient use positive end expiratory pressure (PEEP) valve for use hospital. transport, emergency, and post hospital care to evaluate end lung pressure above atmospheric at the end of exhalation in constant and intermittent gas flow conditions. Intended for patients that the clinician has determined need PEEP. The Disposable Manometer is a single patient use manometer intended to be used for monitoring the patient's airway pressure during ventilation. The manometer is to be used with resuscitation systems.
    Device Description
    Foremount Disposable PVC Resuscitators are portable medical devices used to temporarily augment ventilation in patients during ventilatory insufficiency or ventilatory failure. They consist of Ventilation Bag, Patient Valve, Intake Valves, Reservoir Bag, Oxygen Tubing, Cushion Mask, and optional Diverter Ring, PEEP Valve and Manometer. Foremount Disposable PVC Resuscitators come in three sizes along with a ventilation bag: - . Infant - Less than or equal to 10 kg - Child less than or equal to 23 kg ● - Adult Greater than 23 kg. ● The ventilation bags are available in three sizes based upon the intended patient population. They are provided with masks in three sizes (#1 - Infant, #3 - Child, and #5 - Adult). The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 40 cmH2O pop off valve for Child and Infant models. The patient valve includes a duck-bill valve to prevent rebreathing and incorporates a 60 cmH2O pop off valve for Adult models.
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    K Number
    K152931
    Device Name
    Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
    Manufacturer
    AMBU A/S
    Date Cleared
    2016-08-29

    (329 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Product Code :

    BTM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ambu SPUR II resuscitator is a single patient use resuscitator intended for pulmonary resuscitation. The range of application for each version is: -Adult: Adults and children with a body weight more than 30 kg (66lbs). -Paediatric: infants and Children with a body weights up to 30 kg (66lbs). -Infant: Neonates and infant with a body weight up to 10kg (22lbs).
    Device Description
    Ambu SPUR II Resuscitator is intended for manual pulmonary resuscitation. It is a disposable device intended for Single Patient Use only. Ambu SPUR II Resuscitator is available in three sizes: Adult, Pediatric and Infant. The main components of the product are a patient valve, a bag, an inlet valve, a reservoir bag/tube and an oxygen tube. The patient valve directs the ventilation air through a patient connector into the patient airway and directs the patient expiration air through an expiration connector. The patient connector is constructed to turn around its own axis enabling the resuscitator to turn in relation to connected masks or endotracheal tubes. A pressure limiting valve (40 cmHzO) with an override mechanism is placed in the patient valve housing of all Pediatric and Infant resuscitators. For the Adult resuscitators a pressure limiting valve is optional. M-Port is mounted in the patient valve housing and provides access to the inspiratory and expiratory gas flow allowing connection of a syringe for drug delivery or a qas sampling line for measuring side stream EtCO2. When the M-Port is not used it is sealed with a cap and the resuscitator operates as a resuscitator without the M-Port. The M-Port is an optional feature. The bag of the resuscitator is made of a flexible and elastic material. which ensures the bag to have sufficient compression and recoiling properties. When the bag is compressed, air is delivered via the patient valve to the patient. The inlet valve allows ambient air to flow into the bag and prevents air flowing backwards from the bag through the inlet valve during ventilation. The reservoir consists of either a reservoir bag (closed reservoir) or a reservoir tube (open reservoir) attached to the inlet valve. Supplementary oxygen can be supplied through the oxygen tube attached to the oxygen connector (reservoir bag) or mounted inside the inlet valve assembly (reservoir tube). Supplementary oxygen flows into the reservoir attached to the inlet valve assembly. A Face mask, Endotracheal Tube or Larynqeal Mask/Combitube can be connected to the patient connector of the resuscitator to ensure contact to the patient's airway. The Ambu SPUR II Resuscitator complies with ISO 10651-4: Particular requirements for operator powered resuscitators.
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    K Number
    K132172
    Device Name
    NEONATALIE RESUSCITATOR
    Manufacturer
    LAERDAL MEDICAL A/S
    Date Cleared
    2015-01-15

    (549 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Product Code :

    BTM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support.
    Device Description
    The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support. A manual resuscitator is a resuscitation device in which ventilation of the lungs is produced by the operator compressing the compressible unit of the device, the ventilation bag. The ventilation bag is self-inflating: the compressed bag will refill with ambient air via the bag inlet valve. The resuscitator provides positive pressure ventilation of the lungs (when used with a face mask). The resuscitator can be used to provide supplemental oxygen when used with the oxygen kit, the NeoNatalie Resuscitator Oxygen Kit. When a resuscitator fitted with an oxygen reservoir is used to provide supplemental oxygen, the ventilation bag will refill with oxygen from the oxygen reservoir. The NeoNatalie Resuscitator is made of polysulfone, silicone rubber and stainless steel. The NeoNatalie Resuscitator is reusable resuscitator which may be sterilized by autoclaving.
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    K Number
    K112852
    Device Name
    BABI PLUS NEONATAL RESUSCITATION BAG
    Manufacturer
    A PLUS MEDICAL
    Date Cleared
    2012-01-13

    (87 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Product Code :

    BTM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single patient use manual resuscitation device to temporary ventilate neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg in hospital, transport, emergency and post hospital care environments.
    Device Description
    Single patient use medical device, which temporarily augment ventilation insufficiency or ventilatory failure.
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    K Number
    K102824
    Device Name
    AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
    Manufacturer
    AMBU A/S
    Date Cleared
    2011-01-28

    (121 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Product Code :

    BTM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ambu® Oval Silicone resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support.For use by CPR-trained personnel only, in hospital and pre-hospital settings. The Ambu Oval Silicone resuscitator is reusable. The range of application for the sizes are: Adult: Adults and children with a body weight of more than approx. 30 kg (66 lbs.). Paediatric: Infants and children with a body weight between approx. 10-30 kg (22~66 lbs.)
    Device Description
    Ambu Oval Resuscitators is for manual pulmonary resuscitation and emergency respiratory support. Ambu Oval Resuscitators are in two sizes; Adult & Pediatric. It is a reusable product. The product consists of a resuscitator bag, inlet valve and outlet valve. Oxygen reservoirs can be mounted to the inlet valve. Facemask, Endotracheal Tube or similar device is connected to the resuscitator patient valve to ensure contact to the patient's airway. The inlet valve allows ambient air with or without supplementary oxygen to flow into the bag and prevents air flowing backwards from the bag through the inlet valve during ventilation. When the resuscitator bag is compressed air is delivered via the patient valve to the patient. The bag is made of a self-expanding material, which ensures the bag to have sufficient compression and recoiling properties. Pressure limiting valve (40 cmH2O) with an override mechanism is placed in patient valve housing. On Pediatric resuscitators there are always a Pressure limiting valve and on Adult resuscitators there are product types available with and without Pressure limiting valve. Ambu Ova! Resuscitator complies with ISO 10651-4: Particular requirements for operator powered resuscitators. Ambu Oval Resuscitators have the following physical and performance characteristics: - Provided in two sizes: Adult & Pediatric . - -Reusable - 22 mm (outside) / 15 mm (inside) Patient Connector - - 30 mm Expiratory Connector - - Resuscitator Volume: Pediatric: 635 ml Adult: 1475 ml . - Stoke Volume one hand: Pediatric: 450 ml Adult: 700 ml ・ - Stroke Volume two hands: Pediatric: NA Adult: 1475 ml - - Can be used with ambient air and/or supplementary oxygen. - : Pressure Limiting Valve: 40 cmH2O / 4.0 kPa, and port for attachment of manometer
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