Infant Heel Warmer
510(k) K950680
Infant Heel Warmer is a Class I device made by Baxter Healthcare Corp, cleared under FDA 510(k) K950680 on 23 Aug 1995, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK950680 | Date23 Aug 1995 | StatusActive |
Official records
- FDA 510(k) database K950680
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IMD
- Device class
- Class I
- Regulation
- 21 CFR Part 890.5710
- Advisory committee
- Physical Medicine
- FDA decision
- SN
Similar devices
Other devices filed under FDA product code IMD (Pack, Hot Or Cold, Disposable).
- BK-7182 INSTANT COLD PACK by Fred Sammons, Inc.
- ALLEGIANCE PORTA-WARM MATTRESS by Allegiance Healthcare Corp.
- INSTANT HEAT COMPRESS, CHEMICAL TYPE by Lexington Industries
- INSTANT ICE PACK by Impact Packaging Corp.
- MEDI-PACK by Heatmax Mfg., Inc.
- TEMPRA HEAT PACK by Tempra Technology, Inc.
- ALLEGIANCE KWIK HEAT WARM PERINEAL PACK by Allegiance Healthcare Corp.
- KWICK KOOLER by World Trade Assoc.
- WONDER WARMER by Montvale Products, Inc.
- MAZING HEAT DISPOSABLE WARM PACK by Leebryan Intl.