ClearanceBrief
Panels › Anesthesiology › Product code CAN · Class 1

Regulator, Pressure, Gas Cylinder

Regulation 868.2700

0510(k)s in 12 months (55 all time)
0recalls in 12 months (17 all time)
1recalls that name a 510(k)
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Top companies in CAN

Company510(k)sRecalls
Western / Scott Fetzer Company06
Precision Medical, Inc.21
Puritan Bennett Corp.30
Western - a Scott Fetzer Company03
Airco, Inc.20
Airgas Puritan Medical02
C.G.H. Medical, Inc.20
Instrumentation Industries, Inc.20
Lifeguard Medical Products, Inc.20
Modern Engineering Co., Inc.20
DateFirm and productCodeLinked 510(k)
Apr 12, 2023Western/Scott Fetzer Company
Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR
Open, Classified		 CANNone listed
Oct 16, 2021Western/Scott Fetzer Company
Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603
Open, Classified		 CANNone listed
Oct 16, 2021Western/Scott Fetzer Company
Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
Open, Classified		 CANNone listed
Oct 16, 2021Western/Scott Fetzer Company
Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600
Open, Classified		 CANNone listed
May 8, 2018Dynarex Corporation
Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressure regulator is a device, often called a pressure-reducing valve,
Terminated		 CANNone listed
Nov 13, 2015Precision Medical, Inc.
Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.
Terminated		 CANK901831
Jul 20, 2015Western / Scott Fetzer Company
Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeu
Terminated		 CANNone listed
Jun 23, 2014Western / Scott Fetzer Company
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
Terminated		 CANNone listed
Jun 20, 2013Linde Gas North America Llc
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use d
Terminated		 CANNone listed
Dec 21, 2012Praxair Inc.
Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.
Terminated		 CANNone listed
Oct 15, 2009Western - a Scott Fetzer Company
Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for
Terminated		 CANNone listed
Oct 15, 2009Western - a Scott Fetzer Company
Medical Gas Yoke Assembly. Airgas Portable 2-Cylinder Manifold Cart Model #AGI-2237. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for
Terminated		 CANNone listed
Oct 15, 2009Western - a Scott Fetzer Company
Medical Gas Yoke Assembly. Generic 4-Cylinder Manifold Cart Model #8070. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia
Terminated		 CANNone listed
Oct 14, 2009Airgas Puritan Medical
AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.
Terminated		 CANNone listed
Oct 14, 2009Airgas Puritan Medical
AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Terminated		 CANNone listed
Mar 1, 2006Praxair Distribution Inc.
Praxair Grab ''n Go Vantage unit, model PRX-9496.
Terminated		 CANNone listed
Mar 1, 2006Praxair Distribution Inc.
Praxair Grab ''n Go Vantage unit, model PRX-9495.
Terminated		 CANNone listed

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