Mixer, Breathing Gases, Anesthesia Inhalation
Anesthesiology · 21 CFR 868.5330
Recent MDR events
590 adverse event reports on file
- BIO-MED DEVICESApr 20, 2026MalfunctionBio-med Devices1218704-2026-00001
- BIRD LOW FLOW AIR/O2 BLENDERMar 20, 2026MalfunctionCarefusion/ Vyaire Medical, Inc.MW5185546
- HELIO2 BLENDERJan 21, 2026MalfunctionPrecision Medical, Inc.24130152
- BIO-MED DEVICESOct 21, 2025MalfunctionBio-med Devices1218704-2025-00004
- SECHRIST INDUSTRIES INC.Aug 15, 2025MalfunctionSechrist Industries Inc.2020676-2025-00020
- HYPERINFLATION AMBUMay 28, 2025MalfunctionWestmed Llc2028807-2025-00018
- SECHRIST INDUSTRIES BLENDER 3000-71318May 12, 2025MalfunctionSechrist Industries, Inc22001948
- SUN MEDMay 10, 2025MalfunctionAmbu Inc2028807-2025-00017
- MAXBLEND2, 0-30 LPMApr 17, 2025MalfunctionMaxtec Llc1000117260-2024-00001
- AMBU HYPERINFLATION SYSTEMApr 8, 2025MalfunctionWestmed Llc2028807-2025-00014
Event type breakdown
Recalls
3 recall events for this product code
- Maquet IncTerminatedApr 14, 2005
KION Anesthesia System.
Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality.
Z-0710-05 · View FDA record ↗ - O-Two Medical Technologies, Inc.TerminatedUnknown
O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System
Higher levels of nitrous oxide delivered than specification
Z-2885-2018 · View FDA record ↗ - CAREstream Medical LLCTerminatedUnknown
CAREstream ProNox Nitrous Oxide Delivery System labeled as the following:
Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.
Z-2887-2018 · View FDA record ↗
Registered firms
60 firms currently registered for this product code
Salaera, Llc D.b.a Maxtec
Salt Lake City, UT, US
Hamilton Medical Ag
Domat/Ems Graubunden, CH
Covidien
- Galway, IE
Productos Urologos De Mexico S.a. De C.v.
MEXICALI Baja California, MX
Baldus Sedation Gmbh & Co. Kg
Bendorf Rhineland-Palatinate, DE
Contech Holdings Llc
Brea, CA, US
Nuevo Laredo Directo Al Cliente
Nuevo Laredo Tamaulipas, MX
Witt-gasetechnik Gmbh & Co Kg
Witten North Rhine-Westphalia, DE
Carestream Medical
Sanford, FL, US
Precision Medical, Inc.
NORTHAMPTON, PA, US
Precision Fluidics Division Parker Hannifin Corp.
HATFIELD, PA, US
Volcano Corporation
San Diego, CA, US
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
O-two Medical Technologies, Inc.
Brampton Ontario, CA
Fisher & Paykel Healthcare, Ltd.
EAST TAMAKI Auckland, NZ
Int'air Medical
MONTAGNAT Ain, FR
Fisher & Paykel Healthcare, Inc.
IRVINE, CA, US
Dehas Medical Systems Gmbh
Luebeck Schleswig-Holstein, DE
510(k) clearances
55 clearances for this product code
- Fisher & Paykel Healthcare, Ltd.Jul 14, 2025
K243917 · F&P Optiflow Air/Oxygen Flow Source
- Parker Hannifin CorporationSep 19, 2024
K241465 · Midas Flowmeter; eAVS
- Maxtec, LLCDec 4, 2023
K231895 · Maxtec MaxBlend2+p
- Baldus Sedation GmbH & Co. KGSep 14, 2023
K230987 · FlowStar Analog Mixer Flowmeter
- Baldus Sedation GmbH & Co. KGJul 28, 2023
K222794 · FlowStar Touch Digital Mixer Flowmeter
- Dehas Medical Systems GmbHJan 23, 2023
K221494 · Quality Mix Blender, Oxymixer
- Parker HannifinApr 22, 2021
K202480 · Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
- O-Two Medical Technologies, Inc.Aug 29, 2018
K173205 · Equinox Advantage