WALLABY 4
FDA 510(k) clearance K070180 · decided 2007-05-18
Clearance details
- K-number
- K070180
- Device name
- WALLABY 4
- Applicant
- Respironics Inc., Sleep & Home Respiratory Group
- Decision
- Substantially Equivalent
- Date received
- 2007-01-19
- Decision date
- 2007-05-18
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- LBI
- Device class
- 2
- Regulation number
- 880.5700
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Murrysville, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Respironics Inc.
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 |
|---|---|---|
| SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) (K251308) | Thera B Medical Products | 2026-01-15 |
| BiliWrap (K243372) | Gerium Medical, Ltd. | 2025-05-29 |
| Infant Phototherapy Equipment (K210289) | Bistos Co., Ltd. | 2021-05-28 |
| Neonatal Phototherapy System (K200031) | Avalon Biomedical (Shenzhen) Limited | 2020-10-05 |
| bili-hut (K190899) | Little Sparrows Technologies, Inc. | 2019-09-05 |
| neoBLUE blanket LED Phototherapy System (K182178) | Natus Medical Incorporated | 2018-12-13 |
| BiliLux (K172656) | Draeger Medical Systems, Inc. | 2018-05-01 |
| Skylife (K170585) | Neolight, LLC | 2017-10-27 |
| Bilicocoon™ Phototherapy System (K163526) | Neomedlight | 2017-10-06 |
| neoBLUE compact LED Phototherapy System (K160745) | Natus Medical Incorporated | 2016-12-12 |
| Airborne Phototherapy Light (K160238) | International Biomedical | 2016-06-14 |
| neoBLUE® LED Phototherapy System (K160305) | Natus Medical Incorporated | 2016-05-27 |
Recalls involving this device
No recalls on record reference this clearance.