Giraffe Incubator Carestation CS1— 510(k) K213553

Name: FDA 510(k) clearance K213553
Creator: U.S. Food and Drug Administration
Published: 2022-03-02

Substantially Equivalent

Datex Ohmeda, Inc.

FDA 510(k) clearance K213553 for Giraffe Incubator Carestation CS1, Substantially Equivalent on 2022-03-02. Applicant: Datex Ohmeda, Inc.. Device class: 2.

Clearance details

Applicant: Datex Ohmeda, Inc.
Product code: Code FMZ
Device class: Class 2
Regulation: 21 CFR 880.5400
Advisory panel: General Hospital
Date received: 2021-11-08
Decision date: 2022-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wauwatosa, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMZ

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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
K190494 — Infant Incubator2019-11-25

More clearances from Datex Ohmeda, Inc.

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K254036 — Novii+ Wireless Patch System2026-08-10
K213867 — Carestation 750/750c2023-03-28
K213551 — Giraffe Omnibed Carestation CS12022-03-02
K210384 — CARESCAPE R8602021-11-04
K172702 — Tec 820, Tec 8502018-01-04

Adverse events under product code FMZ

product code FMZ

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 →

Recalls naming K213553

K-number listed on FDA's recall record

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

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213553.

Data sourced from openFDA. This site is unofficial and independent of the FDA.