Giraffe Incubator Carestation CS1
FDA 510(k) clearance K152809 · decided 2015-12-31
Clearance details
- K-number
- K152809
- Device name
- Giraffe Incubator Carestation CS1
- Applicant
- Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-09-28
- Decision date
- 2015-12-31
- Days to decision
- 94 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
+ Add to Predicate Builder ◉ Watch Ohmeda Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 OmniBed Carestation CS1 (K152814) | Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company | 2016-03-17 |
| INFANT INCUBATOR (K132543) | Bistos Co., Ltd. | 2014-07-03 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 20828 recall (Z-0141-2025) | DATEX--OHMEDA, INC. | 2024-10-31 |
| Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer recall (Z-0540-2020) | GE Healthcare, LLC | 2019-12-03 |