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510(k) Data Aggregation

    K Number
    K241339
    Device Name
    Besmed Bacterial Filter and HMEF
    Manufacturer
    Besmed Health Business Corp
    Date Cleared
    2024-11-14

    (185 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Product Code :

    CAH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Besmed HME Filter (Heat and Moisture Exchange) is intended to decrease the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract while administering anesthesia gas, providing artificial respiration, or assisting with ventilation. The Besmed HME Filter is typically placed at the patient's end of the breathing system, specifically between the circuits Y - piece and either the catheter mount or patient airway device. It is essential to note that the Besmed HME Filter is intended for single-use only and should be used on a single patient for up to 24 hours. Besmed HME Filter is intended to be used within critical care and hospital/ institutional environments by qualified personnel. Besmed Bacterial Filter The purpose of the Besmed Bacterial Filter is to diminish the passage of bacteria and viruses to patients receiving anesthesia gas. Besmed Bacterial Filter is designed for utilization with ventilators, anesthesia machines, and open flow systems where there is a need for filtration of inhaled gases. The Besmed Bacterial Filter is a disposable device intended for the exclusive use of a single patient within a 24-hour timeframe. Bacterial Filter is designed for utilization in hospital environments by medical professionals who possess adequate training in the operation of mechanical ventilators, respiratory systems, and humidification systems.
    Device Description
    Besmed HMEF The Besmed HME Filter absorbs the heat and moisture exhaled by the patients. Upon inhalation, it releases the previously retained heat and humidity to the dry inhalation gases. The HME filter is designed with electrostatic cotton for filtration, as well as a heat-preserved and moisture-absorbed paper roll for maintaining the warmth and humidity of the airway in a respiratory system. Additionally, it eliminates bacterial and viral contaminants from the breathing circuit gas. To ensure passive humidification treatment, it is recommended to install the Heat and Moisture Exchanger Filter (HMEF) on the patient's end. Besmed HME Filter is intended for adult and child patients with the tidal volume between 150ml-1000ml. Besmed Bacterial Filter Besmed Bacterial Filter is for single-use purpose. The intended use is achieved through the implementation of an electrostatic filtration mechanism. Transparent and compact housing material makes it easy to check the surface of the filter media for a foreign substance.
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    K Number
    K222917
    Device Name
    Breathing circuit bacterial/viral filter
    Manufacturer
    Shaoxing Haitech Medical Products Co., Ltd
    Date Cleared
    2024-02-15

    (507 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Product Code :

    CAH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K230483
    Device Name
    Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
    Manufacturer
    Passy-Muir, Inc.
    Date Cleared
    2023-09-16

    (205 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Product Code :

    CAH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To filter a patient's inspiratory and expiratory respiratory gasses to remove bacteria and viruses. For non-mechanically ventilated tracheostomy patients who are awake and alert or monitored by a trained healthcare provider or caregiver, where filtration of inspired and/or expired gases is desired. Use up to 24 hours. Environment of use - clinical settings including hospital, sub-acute, pre-hospital, and home. For adults with Tidal Volumes >300 ml and pediatrics with Tidal Volumes >80 ml. Do not use on neonate or infant patients.
    Device Description
    The Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) is a non-sterile, lightweight, single-patient use device for non-mechanically ventilated tracheostomy patients to filter viral, bacterial, and other particulate matter. The filter is intended to fit onto the 15mm hub of a tracheostomy tube. The filter is easy to apply and remove with a gentle twist motion.
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    K Number
    K223258
    Device Name
    TNI Clear-Guard™ 3 angled breathing filter (1545020)
    Manufacturer
    Intersurgical Ltd.
    Date Cleared
    2023-06-15

    (237 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Product Code :

    CAH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used only as part of the softFlow® 50 device to protect the patient, care provider, equipment, or all three from the transference of bacteria or virus through the breathing circuit. The filter should be positioned in a non-humidified gas flow.
    Device Description
    Clear-GuardTM 3 angled Breathing Filter, Model #1545020
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    K Number
    K221472
    Device Name
    Filter and HME/Filter
    Manufacturer
    Ningbo Huakun Medical Equipment Co., Ltd.
    Date Cleared
    2023-02-08

    (264 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Product Code :

    CAH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K221836
    Device Name
    Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
    Manufacturer
    Drägerwerk AG & Co. KGaA
    Date Cleared
    2022-12-07

    (167 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Product Code :

    CAH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Filter CareStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in pediatric (with a tidal volume between 100 and adult patients, depending on the respective device. Filter SafeStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in adult patients. Filter/HME TwinStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and for respiratory use, as well as heat and moisture exchanger for humidifying respired gases for the patient. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in adult, pediatric and neonatal patients, depending on the respective device.
    Device Description
    The devices are breathing circuit filters used to filter the inhaled and/or the exhaled air of the patient against microbiological and particulate matter from the gases in the breathing circuit. They enclose a filter material in a housing that fits to standard breathing system connectors. Additionally, there are breathing system filters combined with a foam to function as HME (Heat and Moisture Exchangers) for passively humidifying the inspired air. The portfolio contains the following types of breathing circuit filters: - Filter CareStar Plus are electrostatic filters for use against contamination with microorganisms - . Filter SafeStar Plus are mechanical filters for use against contamination with microorganisms - Filter/HME TwinStar Plus are filters for use against contamination with microorganisms and for passive humidification of breathing gases
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    K Number
    K221250
    Device Name
    EasyOne Filter
    Manufacturer
    NDD Medizintechnik AG
    Date Cleared
    2022-11-22

    (204 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Product Code :

    CAH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EasyOne Filter is intended to be used in combination with NDD breathing mouthpieces to reduce bacteria, viruses and other particulates from the patient's exhaled air while performing flow measurements, such as spirometry tests. The EasyOne Filter is a single-use device and intended for single-patient use only.
    Device Description
    The EasyOne Filter is a viral, bacterial filter designed to be used with NDD breathing mouthpieces during flow measurements, e.g. for spirometry testing with NDD spirometers. The EasyOne Filter exists in two variants which differ in the connection interface to enable mounting on the EasyOne FlowTube. The EasyOne Filter is composed of two injection molded polymeric parts which enclose a filter medium. The EasyOne Filter is an optional accessory and reduces viruses, bacteria, and other particles that may be released by the patient and thus contaminate the test environment. The EasyOne Filter is non-sterile and for single use.
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    K Number
    K210352
    Device Name
    GGM Breathing Circuit Bacterial Filter
    Manufacturer
    Great Group Medical Co., Ltd.
    Date Cleared
    2022-03-27

    (412 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Product Code :

    CAH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GGM Breathing Circuit Bacterial Filter contains two types of bacterial Filters, namely "Bacterial Filter" with only filtering function and "HME Filter" with heat and moisture exchanger function. Intended patient population: VF-2160, VF-2160-1 and VH-3110 are intended for adult patients with the tidal volume between 250ml-1500ml; VH-3210 is intended for adult patients with the tidal volume between 250ml-1000ml. Bacterial Filter (VF-2160, VF-2160-1) - The Bacterial Filter is intended to reduce the transmission of bacteria and viruses to a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired gases is desired. The Bacterial Filter is single use device for use on a single patient for up to 24hrs. The Bacterial Filter is designed to be used in hospital environments by trained personnel. HME Filter (VH-3110, VH-3210) - HME (Heat and Moisture Exchange) Filter is intended to reduce the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation. HME Filter is normally positioned at the patient end of the breathing system between the circuits Y-piece and the catheter mount or patient airway device. HME Filter is a single use device for use on a single patient for up to 24hrs. HME Filter is designed to be used in hospital environments by trained personnel.
    Device Description
    GGM Breathing Circuit Bacterial Filter contains two types of bacterial filters, namely "Bacterial Filter" with only filtering function and "HME Filter" with heat and moisture exchanger function. Bacterial Filter (models VF-2160, VF-2160-1): Bacterial Filter is a single-used medical device, which is used for filtering the bacteria and virus in the respiratory gas to the patient during the respiratory therapy. VF-2160 and VF-2160-1 are all intended for adult patients with the tidal volume between 250ml-1500ml. HME Filter (models VH-3110, VH-3210): HME Filter is a kind of breathing circuit bacterial filter with the function of passive heat and moisture exchanger (artificial nose). It is a breathing circuit bacterial filter that contains electrostatic cotton for filtration and contains heat preserved and moisture absorbed paper roll for airway heat preservation and humidification. The Heat and Moisture Exchanger Filter (HMEF) should be installed on the patient's end based on the principle of passive humidification treatment. VH-3110 is intended for adult patients with the tidal volume between 250ml-1500ml, and VH-3210 is intended for adult patients with the tidal volume between 250ml-1000ml.
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    K Number
    K211286
    Device Name
    Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
    Manufacturer
    Pall Corporation
    Date Cleared
    2021-11-16

    (203 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Product Code :

    CAH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pal® Ultipor® U55/U55N Filter is a single use bacterial/viral filter and heat and moisture exchanger (HME) for patient side or machine side installation in breathing systems. It is designed to reduce bacterial/viral transmissions between the patient, the equipment and the environment and to reduce the loss of patient heat and humidity. The Ultipor® U55/U55N breathing circuit filter has >99.999% bacterial and >99.995% viral efficiency. The filter is for single patient use for adult patients, and is intended for use within breathing systems in healthcare and home environments where ventilation is required and for a maximum duration of 24 hours.
    Device Description
    The Pall® Ultipor®U55/U55N Breathing Circuit Bacterial Filter and Heat and Moisture Exchanger is a disposable, highly efficient, bi-directional bacterial/viral filter for patient ventilation solutions and is comprised of the following components: - . Filter housing - Is comprised of two molded halves, an inlet housing and an outlet housing that are joined and sealed together. The finished filter housing holds the pleated hydrophobic filter media and provides conical (tapered) fittings on opposing sides of the finished housing to provide connection to the conventional equipment used in the breathing circuit. One side of the finished housing has a coaxial conical fitting, with a conical fitting located on the opposing side. - Hydrophobic filter media Provides airborne bacterial removal efficiency of >99.999%, . airborne viral removal efficiency of >99.995% and waterborne microbial contaminant removal efficiency of 100%. If the filter is used at the patient end, the filter media also acts as a heat and moisture exchanger (HME) by conserving a proportion of the heat and humidity present in the patient's exhaled air and returning it to the patient on the next inspiration.
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    K Number
    K202459
    Device Name
    Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter
    Manufacturer
    Pharma System AB
    Date Cleared
    2021-09-26

    (395 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Product Code :

    CAH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bact Trap filter is a breathing system filter which is designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anaesthetic or ventilator breathing systems. The Bact Trap filter may either be used on the patient side of the ventilator anaesthetic device. The Bact HME/Bact-HME Midi/Pharma Mini is a breathing system filter and a Heat and Moisture Exchanger. The combination of a filter and a Heat and Moisture offer the benefit of both product features. Heat and Moisture Exchangers are used as a conditioning system for mechanically ventilated patients whose uppassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The Bact-HME Midi/Pharma Mini should be used with patients who have a Tidal Volume between 50 - 1500 ml. The Pharma Mini™HME/Filter, Bact-HME™ filter/HME and Bact-HME™ Midi HME/Filter should be used with patients who have a Tidal Volume as follows: - Pharma Mini™ and Bact-Trap™ Mini 50-900ml - · Bact-HME™ Midi and Bact-Trap™ Midi between 100-1200 ml - · Bact-HMETM and Bact-Trap™ between 250-1500 ml The products mentioned above are designed as disposable single patient use and should be changed at least every 24 hours
    Device Description
    The device is a standard breathing circuit bacterial filter used for respiratory management. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit. The function of any breathing circuit is to deliver oxygen and anesthetic gases, and eliminate carbon dioxide. These devices can be placed at the following locations on a breathing circuit: - At the inhalation port of the CO2 absorber of the anesthesia gas machine ● - At the exhalation port of the CO2 absorber of the anesthesia gas machine - At the patient end - at the mask or ET tube - These placements are also common on critical ventilator circuits The Bact-Trap™ filter is a breathing filter which can be used on the patient's side or on the device side of the ventilator/anesthetic device. It is used as a hygienic measure to decontaminate the breathing circuit. The Pharma Mini™ HME/Filter , Bact-HME™ HME/Filter and Bact-HME™ Midi HME/Filter is a breathing system filter and a Heat and Moisture Exchanger (HME). Heat and Moisture Exchangers and HME Filters (HMEF) are designed for patients with a compromised upper airway. HME and HMEFs are used with intubated or tracheostomized patients to collect moisture and heat from the expired gases and return the inhalation cycle. HME and HMEF contain either plastic fibers or open cell polyurethane foam which offer sufficient surface area to mimic or replace the patient's upper airways while intubated. HMEFs have an additional bacterial/viral filter to help prevent the transmission of bacteria and viruses. Bacterial/Viral filter media consists of electrostatically charged fibers and water repellent cover web on both sides. They also work to prevent cross infection to and from the patient during mechanical ventilation of lungs. The proposed devices listed below are single patient use and should be changed every 24 hours in the environment of use. The patient population applicable to these devices are specified by the tidal volumes for the filter/Heat and Moisture Exchanger. The Pharma Mini™HME/Filter, Bact-HME™ filter/HME and Bact-HME™ Midi HME/Filter should be used with patients who have a Tidal Volume as follows: - Pharma Mini™ and Bact-Trap™ Mini 50-900ml - · Bact-HME™ Midi and Bact-Trap™ Midi between 100-1200 ml - · Bact-HMETM and Bact-Trap™ between 250-1500 ml The Pharma Mini, Bact-HME Midi and Bact-HME HME Filters and Bact-Trap Mini, Bact-Trap Midi and Bact-Trap filters are offered in several housing configurations, all of which are typical of filters. These configurations include: - All have standard conical 15 mm / 22 mm fittings for connections ● - Some models have a port version Female luer lock port for gas sampling for end-tidal . CO2 - Some models have a straight version . - Some models have an angled version eliminates the need for a mask elbow . - Straight version packaged with a standard mask elbow for convenience of the user ●
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