Data / Medical devices / United States / Datex-Ohmeda, Inc.
Datex-Ohmeda, Inc.: FDA-registered device maker in Madison, WI, United States, 41 510(k) clearances and 1 PMA approval
Datex-Ohmeda, Inc. is registered with the FDA (registration 2112667) in Madison, WI, United States. It lists 8 device types. The FDA files 41 510(k) clearances and 1 PMA approval under its listings, the newest dated March 28, 2023. 3 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2112667
- Address
- 3030 Ohmeda Drive, Madison, WI, United States, 53718
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- December 15, 1977
- Registered through
- 2027
- Brand names listed
- 2VAP W/ARTICULATING ARM, 3VAP W/ARTICULATING ARM, 7100 Ventilator, ABS Reusable Absorbent Canister, AESTIVA GOLDSEAL, ALADIN2 DES FIXED-FIL, ALADIN2 DES SAF-FIL, ALADIN2 DES SAF-FIL B and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorber, Carbon-Dioxide | BSF | 1 | Manufacturer | accessdata.fda.gov |
| Apparatus, Gas-Scavenging | CBN | 2 | Manufacturer | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Specification developer | accessdata.fda.gov |
| Compressor, Air, Portable | BTI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Gas-Machine, Anesthesia | BSZ | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents | QSF | 3 | Manufacturer | accessdata.fda.gov |
| Vaporizer, Anesthesia, Non-Heated | CAD | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 28, 2023 | K213867 | Carestation 750/750c | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| November 4, 2021 | K210384 | CARESCAPE R860 | CBK | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| January 4, 2018 | K172702 | Tec 820, Tec 850 | CAD | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| November 3, 2017 | K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| August 15, 2017 | K170872 | Aisys CS2 | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| January 21, 2016 | K151570 | Carestation 620/650/650C | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| June 12, 2015 | K142679 | CARESCAPE R860 | CBK | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| April 24, 2015 | K143530 | Aespire View | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| February 3, 2015 | K140575 | ENGSTROM CARESTATION, ENGSTROM PRO | CBK | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| December 20, 2013 | K132530 | GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| August 8, 2013 | K131945 | GE DATEX-OHMEDA AVANCE CS2 | BSZ | Substantially Equivalent | Datex-Ohmeda | accessdata.fda.gov |
| February 6, 2013 | K123125 | GE DATEX-OHMEDA AVANCE CS2 | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| October 12, 2012 | K122445 | AESPIRE 7900, AESPIRE VIEW | BSZ | Substantially Equivalent | Datex-Ohmeda | accessdata.fda.gov |
| December 16, 2011 | K112722 | GE DATEX-OHMEDA AVANCE | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| September 9, 2011 | K111116 | ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 | CBK | Substantially Equivalent | Datex-Ohmeda | accessdata.fda.gov |
| July 20, 2011 | K110213 | GE DATEX-OHMEDA AISYS | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| May 3, 2010 | K093886 | ENGSTROM CARESTATION, ENGSTROM PRO | CBK | Substantially Equivalent | Datex-Ohmeda Inc., A Division of Instrumentarium C | accessdata.fda.gov |
| January 12, 2010 | K092864 | AESPIRE 7900, AESPIRE VIEW | BSZ | Substantially Equivalent | Datex-Ohmeda Inc., A Division of Instrumentarium C | accessdata.fda.gov |
| March 5, 2009 | K090233 | GE DATEX-OHMEDA AISYS | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| October 3, 2008 | K081842 | ENGSTROM CARESTATION, ENGSTROM PRO | CBK | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| August 29, 2008 | K081844 | GE DATEX-OHMEDA AVANCE | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| January 30, 2008 | K073707 | GE DATEX-OHMEDA AISYS | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| June 6, 2007 | K071142 | GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM | BSZ | Substantially Equivalent | Datex-Ohmeda | accessdata.fda.gov |
| December 8, 2006 | K062710 | GE DATEX-OHMEDA ENGSTROM CARESTATION | CBK | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| June 27, 2006 | K061609 | GE DATEX-OHMEDA AISYS | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| June 5, 2006 | K060862 | GE DATEX-OHMEDA ENGSTROM CARESTATION | CBK | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| September 27, 2005 | K051895 | GE DATEX-OHMEDA ENGSTROM CARESTATION | CBK | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| June 21, 2005 | K050860 | GE DATEX-OHMEDA CENTIVA/5 VENTILATOR | CBK | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| March 25, 2005 | K050626 | GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| February 4, 2005 | K050055 | GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| April 22, 2004 | K040743 | MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| October 7, 2003 | K023366 | DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS | CBK | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| June 26, 2003 | K031027 | DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) | CAD | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| January 30, 2002 | K012924 | DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER | CAD | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| September 21, 2000 | K002878 | DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER | CAD | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| May 11, 2000 | K000706 | DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| April 25, 2000 | K993410 | DATES-OHMEDA AESTIVA SMARTVENT MRI | BSZ | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| April 12, 2000 | K000275 | DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA | CAD | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| January 21, 1999 | K990132 | DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC | CAD | Substantially Equivalent | Datex-Ohmeda, Inc. | accessdata.fda.gov |
| June 2, 1993 | K925580 | OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD | BSZ | Substantially Equivalent | Ohmeda Anesthesia Systems Therapy Group | accessdata.fda.gov |
| October 6, 1992 | K913593 | OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER | CAD | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 17, 2022 | P210018 | Et Control | QSF | 0 | March 17, 2022 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 30, 2026 | 99649 | Class II | Ongoing | Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000 | Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be | accessdata.fda.gov |
| July 12, 2024 | 95045 | Class I | Ongoing | Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only b | Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. | accessdata.fda.gov |
| December 29, 2023 | 93715 | Class I | Ongoing | EVair air compressor, model numbers: M1230849 and M1230847 | GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstrm Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possibl | accessdata.fda.gov |
Compare with other makers
- All makers of Gas-Machine, Anesthesia
- All makers of Ventilator, Continuous, Facility Use
- All makers of Vaporizer, Anesthesia, Non-Heated
- All makers of Compressor, Air, Portable
- All makers of Apparatus, Gas-Scavenging
- All makers of Absorber, Carbon-Dioxide
Updated September 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.