Giraffe Incubator Carestation CS1— 510(k) K152809

Clearance details

Applicant

Ohmeda Medical, A Division of Datex-Ohmeda, Inc.

Product code

Code FMZ

Device class

Class 2

Regulation

21 CFR 880.5400

Advisory panel

General Hospital

Date received

2015-09-28

Decision date

2015-12-31

Decision

Substantially Equivalent

Clearance type

Special

Location

Laurel, MD, US

• K260326 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)2026-07-28
• K251619 — Babyleo TN5002026-02-13
• K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)2025-10-22
• K243437 — mOm Essential Incubator (ME1)2025-08-14
• K213553 — Giraffe Incubator Carestation CS12022-03-02

• K122267 — GIRAFFE AND PANDA WARMERS2012-10-02
• K101804 — GIRAFFE AND PANDA WARMERS2010-07-21

Death

2

Malfunction

457

Other

1

Total

460

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0141-2025 — GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 2082844-002-01093489; 9) 2082844-002-01113262; 10) 2082844-002-01113711; 11) 2082844-002-01123085; 12) 2082844-002-01123918; 13) 2082844-002-01128966; 14) 2082844-002-01133042; 15) 2082844-002-01146447; 16) 2082844-002-100205; 17) 2082844-002-100749; 18) 2082844-002-100752; 19) 2082844-002-100995; 20) 2082844-002-101425; 21) 2082844-002-523548; 22) 2082844-002-529928; 23) 2082844-002-594800; 24) 2082844-002-643544; 25) 2082844-002-925841; 26) 2082844-002-965540; 27) 2082844-002-982916; 28) 2082844-002-983420; 29) 2082844-002-993905; 30) 2082844-002-995018; 31) 2082844-002-995799; 32) 2082844-002-998943; Radiant infant warmerClass I·Completed·DATEX--OHMEDA, INC.·20230606
• Z-0540-2020 — Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmerClass I·Terminated·GE Healthcare, LLC·20191011
• Z-0480-2019 — Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1Class II·Terminated·GE Healthcare, LLC·20180925

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152809.