Panda iRes Warmer, Giraffe Warmer
FDA 510(k) clearance K201628 · decided 2021-02-12
Clearance details
- K-number
- K201628
- Device name
- Panda iRes Warmer, Giraffe Warmer
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2020-06-16
- Decision date
- 2021-02-12
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- FMT
- Device class
- 2
- Regulation number
- 880.5130
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Wauwatosa, WI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch GE Healthcare
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 |
|---|---|---|
| Babyroo TN300 (K243606) | Draeger Medical Systems, Inc. | 2025-01-17 |
| Babyroo TN300 (K230278) | Draeger Medical Systems, Inc. | 2023-05-30 |
| Giraffe Omnibed Carestation CS1 (K213551) | Datex Ohmeda, Inc. | 2022-03-02 |
| HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable (K200319) | Deroyal Industries, Inc. | 2020-04-02 |
| Hydro-Temp Neonatal Skin Temperature Probe Cover (K191425) | Deroyal Industries, Inc. | 2020-01-21 |
| NuBorne Infant Warmer (K173516) | International Biomedical | 2018-08-17 |
| GIRAFFE AND PANDA WARMERS (K123309) | Ohmeda Medical | 2013-02-05 |
| RESUSCITAIRE WITH AUTOBREATH (K120642) | Draeger Medical Systems, Inc. | 2012-11-02 |
| GIRAFFE AND PANDA WARMERS (K122267) | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2012-10-02 |
| LULLABY TM WARMER (K121625) | Wipro GE Healthcare Private, Ltd. | 2012-09-14 |
| SUNFLOWER WARNER (K120937) | Atom Medical Corporation | 2012-07-06 |
| INFA WARMER I (K102227) | Atom Medical Corporation | 2011-01-21 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated R recall (Z-2358-2026) | Datex-Ohmeda Inc | 2026-06-18 |
| GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide recall (Z-3080-2024) | Wipro GE Healthcare Private Ltd. | 2024-09-20 |
| GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3 recall (Z-3081-2024) | Wipro GE Healthcare Private Ltd. | 2024-09-20 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Senographe Pristina 3D (P130020/S005) | GE Healthcare | 2025-11-21 |
| Invenia ABUS Premium, Invenia ABUS Prime (P110006/S011) | GE Healthcare | 2025-02-04 |
| Senographe Pristina 3D and SenoClaire (P130020/S004) | GE Healthcare | 2021-03-23 |
| Invenia ABUS (Automated Breast Ultrasound System) 2.0 (P110006/S010) | GE Healthcare | 2018-08-24 |
| Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009) | GE Healthcare | 2018-05-11 |
| Senographe Pristina 3D (P130020/S003) | GE Healthcare | 2017-12-28 |
| Invenia ABUS Autoated Breast Ultrasound System (P110006/S008) | GE Healthcare | 2017-09-07 |
| Invenia ABUS - Automated Breast Ultrasound System (P110006/S007) | GE Healthcare | 2017-05-01 |