Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Datex-Ohmeda, Inc. — Predicate Candidate Screening
61 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
225 days90th percentile
61clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260326 | Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Care | Datex-Ohmeda, Inc. | 2026-07-28 | 179 | 0 |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Caresta | Datex-Ohmeda, Inc. | 2025-10-22 | 145 | 0 |
| K213867 | Carestation 750/750c | Datex-Ohmeda, Inc. | 2023-03-28 | 473 | 4 |
| K213551 | Giraffe Omnibed Carestation CS1 | Datex Ohmeda, Inc. | 2022-03-02 | 114 | 5 |
| K213553 | Giraffe Incubator Carestation CS1 | Datex Ohmeda, Inc. | 2022-03-02 | 114 | 1 |
| K210384 | CARESCAPE R860 | Datex-Ohmeda, Inc. | 2021-11-04 | 268 | 0 |
| K172702 | Tec 820, Tec 850 | Datex-Ohmeda, Inc. | 2018-01-04 | 119 | 4 |
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compac | Datex-Ohmeda, Inc. | 2017-11-03 | 120 | 10 |
| K170872 | Aisys CS2 | Datex-Ohmeda, Inc. | 2017-08-15 | 145 | 3 |
| K151570 | Carestation 620/650/650C | Datex-Ohmeda, Inc. | 2016-01-21 | 225 | 10 |
| K142679 | CARESCAPE R860 | Datex-Ohmeda, Inc. | 2015-06-12 | 266 | 5 |
| K143530 | Aespire View | Datex-Ohmeda, Inc. | 2015-04-24 | 133 | 1 |
| K140575 | ENGSTROM CARESTATION, ENGSTROM PRO | Datex-Ohmeda, Inc. | 2015-02-03 | 334 | 0 |
| K132530 | GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) | Datex-Ohmeda, Inc. | 2013-12-20 | 130 | 1 |
| K123125 | GE DATEX-OHMEDA AVANCE CS2 | Datex-Ohmeda, Inc. | 2013-02-06 | 125 | 3 |
| K112722 | GE DATEX-OHMEDA AVANCE | Datex-Ohmeda, Inc. | 2011-12-16 | 88 | 4 |
| K110213 | GE DATEX-OHMEDA AISYS | Datex-Ohmeda, Inc. | 2011-07-20 | 176 | 7 |
| K090233 | GE DATEX-OHMEDA AISYS | Datex-Ohmeda, Inc. | 2009-03-05 | 34 | 2 |
| K081842 | ENGSTROM CARESTATION, ENGSTROM PRO | Datex-Ohmeda, Inc. | 2008-10-03 | 95 | 0 |
| K081844 | GE DATEX-OHMEDA AVANCE | Datex-Ohmeda, Inc. | 2008-08-29 | 60 | 4 |
| K073707 | GE DATEX-OHMEDA AISYS | Datex-Ohmeda, Inc. | 2008-01-30 | 30 | 2 |
| K072512 | MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE A | Datex-Ohmeda, Inc. | 2007-10-03 | 27 | 0 |
| K062710 | GE DATEX-OHMEDA ENGSTROM CARESTATION | Datex-Ohmeda, Inc. | 2006-12-08 | 88 | 2 |
| K061609 | GE DATEX-OHMEDA AISYS | Datex-Ohmeda, Inc. | 2006-06-27 | 18 | 1 |
| K060862 | GE DATEX-OHMEDA ENGSTROM CARESTATION | Datex-Ohmeda, Inc. | 2006-06-05 | 68 | 1 |
| K051895 | GE DATEX-OHMEDA ENGSTROM CARESTATION | Datex-Ohmeda, Inc. | 2005-09-27 | 76 | 0 |
| K050860 | GE DATEX-OHMEDA CENTIVA/5 VENTILATOR | Datex-Ohmeda, Inc. | 2005-06-21 | 77 | 0 |
| K050676 | GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) | Datex-Ohmeda, Inc. | 2005-04-12 | 27 | 3 |
| K050626 | GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM | Datex-Ohmeda, Inc. | 2005-03-25 | 14 | 1 |
| K050597 | GE DATEX-OHMEDA ENGSTROM CARESTATION | Datex-Ohmeda, Inc. | 2005-03-25 | 16 | 0 |
| K043120 | MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI | Datex-Ohmeda, Inc. | 2005-03-01 | 109 | 0 |
| K050055 | GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM | Datex-Ohmeda, Inc. | 2005-02-04 | 24 | 1 |
| K041775 | GE DATEX-OHMEDA ENGSTROM CARESTATION | Datex-Ohmeda, Inc. | 2004-10-26 | 117 | 0 |
| K041524 | GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM | Datex-Ohmeda, Inc. | 2004-09-20 | 104 | 0 |
| K040831 | DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 35 | Datex-Ohmeda, Inc. | 2004-09-02 | 155 | 5 |
| K042154 | GE DATEX-OHMEDA AISYS CARESTATION | Datex-Ohmeda, Inc. | 2004-08-31 | 21 | 3 |
| K040743 | MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM | Datex-Ohmeda, Inc. | 2004-04-22 | 30 | 0 |
| K031124 | POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR | Datex-Ohmeda, Inc. | 2003-12-04 | 240 | 2 |
| K023366 | DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS | Datex-Ohmeda, Inc. | 2003-10-07 | 364 | 2 |
| K031027 | DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) | Datex-Ohmeda, Inc. | 2003-06-26 | 86 | 0 |
| K031479 | AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYST | Datex-Ohmeda, Inc. | 2003-06-06 | 29 | 0 |
| K021955 | TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & | Datex-Ohmeda, Inc. | 2002-10-08 | 116 | 2 |
| K012924 | DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER | Datex-Ohmeda, Inc. | 2002-01-30 | 152 | 0 |
| K010463 | DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRE | Datex-Ohmeda, Inc. | 2001-03-15 | 27 | 1 |
| K002478 | S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A0 | Datex-Ohmeda, Inc. | 2000-10-05 | 55 | 0 |
| K002878 | DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER | Datex-Ohmeda, Inc. | 2000-09-21 | 6 | 0 |
| K002158 | S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SO | Datex-Ohmeda, Inc. | 2000-09-06 | 51 | 0 |
| K000647 | DATEX-OHMEDA NETWORK AND CENTRAL | Datex-Ohmeda, Inc. | 2000-07-13 | 136 | 0 |
| K001688 | DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER | Datex-Ohmeda, Inc. | 2000-06-30 | 28 | 0 |
| K000892 | DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, | Datex-Ohmeda, Inc. | 2000-06-16 | 88 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda