FETAL PILLOW
FDA 510(k) clearance DEN150053 · decided 2017-07-27
Clearance details
- K-number
- DEN150053
- Device name
- FETAL PILLOW
- Applicant
- Safe Obstetric Systems, Ltd.
- Decision
- Unknown
- Date received
- 2015-11-18
- Decision date
- 2017-07-27
- Days to decision
- 617 days
- Clearance type
- Direct
- Product code
- PWB
- Device class
- 2
- Regulation number
- 884.4350
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Shenfield, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Safe Obstetric Systems
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 |
|---|---|---|
| Fetal Pillow (K243799) | CooperSurgical, Inc. | 2025-08-29 |
Recalls involving this device
No recalls on record reference this clearance.