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510(k) Data Aggregation
K Number
K241465Device Name
Midas Flowmeter; eAVS
Manufacturer
Parker Hannifin Corporation
Date Cleared
2024-09-19
(119 days)
Product Code
BZR, CBN
Regulation Number
868.5330Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Midas Flowmeter is intended for use as a continuous flow conscious sedation system to deliver a mixture of nitrous oxide and oxygen gases to a patient. When used with the electronic automatic vacuum switch (eAVS), the Midas Flowmeter is used to control the scavenging of waste analgesic gas.
Device Description
The Midas Flowmeter is used within a healthcare environment during a nitrous oxide (N20)/oxygen (O2) conscious sedation system. The device is a digitally controlled, software driven, continuous flow device that precisely meters nitrous oxide and oxygen medical gases and delivers gas mixtures to a conscious, spontaneously breathing patient. The Midas Flowmeter uses electronic mechanisms to control the flowrate and mixture percentage of gases delivered to a patient. The optional eAVS is an accessory to the Midas Flowmeter. It is used within the nitrous oxide/oxygen conscious sedation system to allow removal of waste analgesic gases through a connected vacuum source. The eAVS connects the exhalation line of the patient's breathing circuit to vacuum tubing from the vacuum source and controls the vacuum flowrate (i.e., scavenging flowrate). The eAVS is specifically designed to work with the Midas Flowmeter and all functionality control of the eAVS has been integrated into the user interface of the Midas Flowmeter.
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K Number
K231895Device Name
Maxtec MaxBlend2+p
Manufacturer
Maxtec, LLC
Date Cleared
2023-12-04
(159 days)
Product Code
BZR, CAP, CCL
Regulation Number
868.5330Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Maxtec MaxBlend 2+p is intended to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen and pressure being delivered to infant, pediatric, and adult patients. It is a restricted medical device intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare settings, i.e., hospital, subacute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life-supporting device or life sustaining device.
Device Description
The Maxtec MaxBlend 2+p is an oxygen delivery device which incorporates an air/oxygen blender, battery powered oxygen and pressure monitor, and an adjustable flowmeter, all in a single assembly. The integral air/oxygen blender provides precise mixing of medical grade air and oxygen. The flowmeter provides control of the flow rate delivered. The oxygen monitor measures the oxygen concentration from the blender's gas flow, displays these measured concentrations, and provides user selectable high and low oxygen alarms. It also allows the user to monitor pressure simultaneously using adjustable high and low alarm limits.
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K Number
K230987Device Name
FlowStar Analog Mixer Flowmeter
Manufacturer
Baldus Sedation GmbH & Co. KG
Date Cleared
2023-09-14
(161 days)
Product Code
BZR
Regulation Number
868.5330Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient
Device Description
This is a device which can precisely dose a mixture of medical oxygen and medical nitrous oxide, depending on the adjusted mixture, for the sedation of patients in hospitals and at the dentist. The operator, a dentist is able to adjust the total flow and the concentration of nitrous oxide of this flow. Depending on these settings the level of sedation of the patient can be controlled by the operator. The FlowStar ® Analog Mixer device has been created with the following safety features. The total flow emitted can consist of a maximum of 70 % nitrous oxide, the mix up of gas types is prevented by mechanical encodings and the flow of pure nitrous oxide in the absence of a missing oxygen supply is prevented by a fail-safe device.
Two rotary knobs are used to select the desired total flow and N20/O2 gas mixture. The total flow can consist of between 0 (100% O₂) and 70 (30% O₂) percent N₂O. The minimum output of 30 % O2 prevents from a hypoxic mixture for the patient. The FlowStar® Analog Mixer device has an integrated O2 Flush knob which delivers at least over 40 l/min of pure oxygen if the user presses the knob to flush the N20 out of the patient circuit after the treatment or in the situation the patient is over sedated.
The FlowStar Analog Mixer device has an alarm system which generates an alarm in the case of an insufficient O2 supply. The device will shut off the sedation when the O2 supply reaches a critical level.
The FlowStar ® Analog Mixer has an integrated Bag T. The mixed gas to it. The Bag T is a device with one additional input and two outputs. The additional input is a valve which opens when the adjusted total flow is too low for the patient. The gas mixture is then enriched with additional ambient air. The first output of the Bag T is for the connected breathing bag which is filled by the mixing device when the patient exhales and is emptied when the patient inhales. The second output leads the gas mixture to the connected scavenger system and finally to the patient
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K Number
K222794Device Name
FlowStar Touch Digital Mixer Flowmeter
Manufacturer
Baldus Sedation GmbH & Co. KG
Date Cleared
2023-07-28
(315 days)
Product Code
BZR
Regulation Number
868.5330Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient.
Device Description
The device will be available in two models: (Details below) FLOWSTAR TOUCH DIGITAL MIXER FLOWMETER 50 %, and FLOWSTAR TOUCH DIGITAL MIXER FLOWMETER 70 %.
50% and 70% represent the maximum nitrous oxide concentration. The FlowStar Touch O2- N₂O Mixer for Analgesia is a device which can precisely dose a mixture of medical oxygen and medical nitrous oxide, depending on the adjusted mixture, for the sedation of patients in hospitals and at the dentist. The operator, a doctor or a dentist is able to adjust the total flow and the concentration of nitrous oxide of this flow. Depending on these settings the level of sedation of the patient can be controlled by the operator. The Baldus® Touch O2- N2O Mixer for Analgesia device has been created with the following safety features. The total flow emitted can consist of a maximum of 70 % nitrous oxide, the mix up of gas types is prevented by mechanical encodings and the flow of pure nitrous oxide in the absence of a missing oxygen supply is prevented by a fail-safe device. An integrated Touch pad is used to select the desired N₂O /O2 gas mixture. The total flow can consist of between 0 (100% O2) and 70 (30% O2) percent N₂O. The minimum output of 30 % O2 prevents from a hypoxic mixture for the patient. The FlowStar TouchO2- N2O Mixer for Analgesia device has an integrated O2 Flush function which delivers at least 30 l/min of pure oxygen to flush the N20 out of the patient circuit after the treatment. The FlowStar TouchO2- N₂O Mixer for Analgesia device has an alarm system which generates an alarm in the case of an insufficient O2 supply. The device will shut off the sedation when the O2 supply reaches a critical level. The gas mixture output of the FlowStar TouchO2- N2O Mixer for Analgesia device is connected to the Bag T. The Bag T is a device with two inputs and two outputs. One input is the gas mixture from the mixing device. The other input is a valve which opens when the adjusted total flow is too low for the patient. The gas mixture is then enriched with additional ambient air. The first output of the Bag T is for the connected breathing bag which is filled when the patient exhales and is emptied when the patient inhales. The second output leads the gas mixture to the scavenger system and finally to the patient. The main accessories for the proposed device are a Breathing Bag and a Double Mask Scavenger System.
The device includes a microprocessor-controlled valve system that precisely meters Oxygen and Nitrous Oxide gases for analgesic purposes. The inputs of the touchpad influence the gas flow inside of the device. The firmware is considered to be of a moderate level of concern.
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K Number
K221494Device Name
Quality Mix Blender, Oxymixer
Manufacturer
DEHAS Medical Systems GmbH
Date Cleared
2023-01-23
(245 days)
Product Code
BZR
Regulation Number
868.5330Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The air-oxygen mixer Quality Mix is used to administer a continuous, precise mix of medical air and medical oxygen through its outlet ports - to infants, children and adults. The exact fractional inspiratory oxygen concentration (FiO2) corresponds to the selected FiO2 setting on the control knob (dial).
It is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician in professional healthcare settings.
This product is not intended for use as a life supporting device.
Warning: By using flows above 70 LPM, the risk of high flow such as ar trapping, barotrauma, and gastric insufflation (leading to possible aspiration) can occur.
Device Description
The air-oxygen blender Quality Mix is a compact air/oxygen mixing device, which provides a precise mixing of medical grade air and oxygen gases. The blender is a pneumatic powered device with flowmeters which can be connected to outlet ports to regulate the gas flow.
The Quality Mix series medical air / oxygen blender includes following models: Quality Mix High Flow; Quality Mix High Flow XL and Quality Mix Low Flow; Quality Mix Low Flow XL.
The Quality Mix series air / oxygen blender is designed, tested and manufactured in accordance with the standard ISO 11195:2018 Gas mixers for medical use - Stand - alone qas mixers.
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K Number
K202480Device Name
Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
Manufacturer
Parker Hannifin
Date Cleared
2021-04-22
(237 days)
Product Code
BZR
Regulation Number
868.5330Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitronox Plus is intended to provide a mixture of N20/02, on demand, to a conscious, spontaneously breathing patient. The Nitronox Plus is designed for use with adult and pediatric patients and is not intended to be used with infants or neonates.
Device Description
The Nitronox Plus is a portable "on demand" analgesia system used to deliver a mixture of nitrous oxide and oxygen gases to a conscious, spontaneously breathing patient. The device is designed for use with adult and pediatric patients and is not intended to be used with infants or neonates. It is only for use in a healthcare setting by healthcare professionals. The Nitronox Plus is available in three models which differ only in adjustability and maximum ratio of nitrous oxide that can be delivered. The Nitronox Plus features a 0-70% N2O adjustable model, 0-50% N2O adjustable model, and 50% N2O/50% O2 fixed model.
The Nitronox Plus is a pneumatic system. Oxygen and nitrous oxide are supplied to the device through flexible hoses. Inlet gas is regulated and equalized through the use of an oxygen piloted dual diaphragm regulator. The inlet pressure of both gases and the mixed gas pressure are displayed on the front panel of the device through the use of pressure gauges. The device is designed to function with a medical breathing circuit and face mask or mouthpiece accessory.
Delivery of mixed gas starts with a patient's demand; upon inhalation through a face mask or mouthpiece, a demand valve opens and supplies mixed gas to the patient through the connected Medical Breathing Circuit. In adjustable models, the healthcare professional is able to set the desired concentration through the use of a control knob on the front panel. Mixed gas is supplied through the breathing circuit until inhalation ceases.
The Nitronox Plus contains several safety features. Pneumatically powered alarms for both gas inlets alert the user when either gas supply begins to deplete. The device will also maintain delivery of the set concentration with depleting oxygen pressure. Once the oxygen pressure drops below a certain threshold, the device will allow ambient air to be delivered through an Emergency Air Intake valve. The device also features a key lock to control the nitrous oxide gas supply, allowing healthcare professionals to prevent unauthorized use of the device.
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K Number
K173205Device Name
Equinox Advantage
Manufacturer
O-Two Medical Technologies Inc.
Date Cleared
2018-08-29
(331 days)
Product Code
BZR
Regulation Number
868.5330Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen, on demand, to a conscious, spontaneously breathing patient.
Device Description
Equinox® Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device intended to administer an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen mixture to provide pain relief, on demand, to a conscious, spontaneously breathing, patient.
The device provides two input connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has a control knob for turning ON or OFF the device. When it is turned ON, the output of N2O/O2 gas mixture will only be administered by an inspiratory effort by the patient.
A selection knob is used to select desired N20/02 gas mixture. The adjustable range is from 25% O2 (NJO 75%) to 100% O2 (N3O 0%), with the minimum of 25% oxygen output to eliminate the possibility of delivering a hypoxic mixture.
The Oxygen Enrichment Function is designed to provide 30 L/min of 100% oxygen in order to flush any residual gas from the patient circuit following the completion of the patient treatment.
The built-in pneumatically powered alarm system will generate both visual and audible alarms should either nitrous oxide or oxygen input fall below 40 PSI, and the device will be automatically shut off should oxygen input falls below 35 PSI.
The main accessories for the proposed device are a disposable Patient Circuit and a Mouth Piece or a universal Face Mask.
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K Number
K161718Device Name
MaxBlend 2, MaxBlend Lite
Manufacturer
Maxtec, LLC
Date Cleared
2016-10-27
(127 days)
Product Code
BZR, CCL
Regulation Number
868.5330Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MaxBlend 2 and MaxBlend Lite are designed to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen being delivered to infant, pediatric, and adult patients. It is a restricted medical device intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare settings, i.e.. hospital, sub-acute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life supporting device.
Device Description
The MaxBlend family of blenders, MaxBlend 2 and MaxBlend Lite, are oxygen delivery devices which incorporate an air/oxygen blender, battery powered oxygen monitor, and an adjustable flowmeter, all in a single assembly. The air/oxygen blender provides precise mixing of medical grade air and oxygen. The flowmeter provides control of the flow rate delivered. The oxygen monitor measures the oxygen concentration from the blender's gas flow, displays these measured concentrations, and provides user selectable high and low oxygen alarms.
The MaxBlend 2 incorporates the air/oxygen blender within its enclosure. The MaxBlend Lite may be provided with or without the blender component pre-assembled, allowing the user to install the oxygen monitor/flowmeter module, the MaxBlend Lite component, on an existing compatible blender. The addition of the MaxBlend Lite module is intended to improve the safety of an existing air/oxygen blender that is in the user's possession. Both devices use the exact same oxygen monitor sensor and electronics, MaxO2ME (K153659). Both devices use the exact same components/assemblies in the flowmeter and sensor bleed manifold which form the gas pathway to the patient. The only substantive difference is the form of the enclosure for the monitor electronics.
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K Number
K142291Device Name
GMX Series Medical Air/Oxygen Blender
Manufacturer
GENTEC (SHANGHAI) CORPORATION
Date Cleared
2015-05-19
(274 days)
Product Code
BZR
Regulation Number
868.5330Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GMX Series Medical Air/Oxygen Blender is designed to dispense a continuous blend of Medical Air and Oxygen via outlet ports to infant, pediatric, and adult patients.
Device Description
The GMX Series Medical Air/Oxygen blender is a restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where delivery of air/oxygen mixtures is required. The GMX Series Medical Air/Oxygen blender includes two models: GMX30U-AIR/O2, GMX120U-AIR/O2. The GMX Series Medical Air/Oxygen blender is designed, tested, and will be manufactured in accordance with the following standard: ISO 11195 Gas mixers for medical use - Stand-alone gas mixers 1995.
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K Number
K113687Device Name
EQUINOX RELIEVE
Manufacturer
O-TWO MEDICAL TECHNOLOGIES, INC.
Date Cleared
2012-04-30
(137 days)
Product Code
BZR, BTL
Regulation Number
868.5330Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is indicated for delivering a 50%/ 50% mixture of nitrous oxide and oxygen, on demand, to a conscious, spontaneously breathing patient.
Device Description
The proposed Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device designed to provide a 50/50% nitrous oxide and oxygen mixture. The device provides two input connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has only one control for turning ON or OFF the device. When it is turned ON, the output of N20/02 gas mixture will only be activated by an inspiratory effort by the patient. The out put of N20/O2 gas mixture is pre-set at 50/50%. Neither the patient nor medical personnel are able to adjust, eliminating the risk of delivering a hypoxic mixture. The gas specific built-in alarm system will generate both visual and audible alarms should either nitrous oxide or oxygen input fall below 40 PSI, and the device will automatically shut off should either nitrous oxide or oxygen input fall below 35 PSL. The device is also equipped with a secondary "fail safe" circuit that will activate an alarm and shut off the device should internal malfunction occur in the mixer or any internal hoses rupture or kink. The main accessories for the proposed device are a disposable Patient Circuit and a universal Face Mask.
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