Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152809 | Giraffe Incubator Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2015-12-31 | 94 | 2 |
| K122267 | GIRAFFE AND PANDA WARMERS | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2012-10-02 | 64 | 5 |
| K101804 | GIRAFFE AND PANDA WARMERS | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2010-07-21 | 23 | 1 |
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