Giraffe OmniBed Carestation CS1
FDA 510(k) clearance K152814 · decided 2016-03-17
Clearance details
- K-number
- K152814
- Device name
- Giraffe OmniBed Carestation CS1
- Applicant
- Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company
- Decision
- Substantially Equivalent
- Date received
- 2015-09-28
- Decision date
- 2016-03-17
- Days to decision
- 171 days
- Clearance type
- Special
- Product code
- FMZ
- Device class
- 2
- Regulation number
- 880.5400
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Laurel, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1) (K260326) | Datex-Ohmeda, Inc. | 2026-07-28 |
| Babyleo TN500 (K251619) | Drägerwerk AG & Co. KGaA | 2026-02-13 |
| Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (K251663) | Datex-Ohmeda, Inc. | 2025-10-22 |
| mOm Essential Incubator (ME1) (K243437) | Mom Incubators Limited | 2025-08-14 |
| Giraffe Incubator Carestation CS1 (K213553) | Datex Ohmeda, Inc. | 2022-03-02 |
| Infant Incubator (K190494) | Ningbo David Medical Device Co., Ltd. | 2019-11-25 |
| Babyleo TN500 (K182859) | Dragerwerk AG & CO Kgaa | 2019-02-22 |
| Isolette 8000 Plus (K182977) | Draeger Medical Systems, Inc. | 2018-11-21 |
| Isolette 8000 plus (K172154) | Draeger Medical Sytems, Inc. | 2018-04-19 |
| Babyleo TN500 (K162821) | Draegerwerk AG & CO Kgaa | 2017-06-23 |
| Giraffe Incubator Carestation CS1 (K152809) | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2015-12-31 |
| INFANT INCUBATOR (K132543) | Bistos Co., Ltd. | 2014-07-03 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infa recall (Z-2476-2026) | GE Medical Systems, LLC | 2026-06-17 |
| Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-50 recall (Z-2477-2026) | GE Medical Systems, LLC | 2026-06-17 |
| GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant war recall (Z-0140-2025) | DATEX--OHMEDA, INC. | 2024-10-31 |
| GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubato recall (Z-0048-2025) | DATEX--OHMEDA, INC. | 2024-10-17 |
| Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, recall (Z-2100-2023) | DATEX--OHMEDA, INC. | 2023-07-06 |
| Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestatio recall (Z-0539-2020) | GE Healthcare, LLC | 2019-12-03 |