InfaTherm Disposable Infant Warming Mattress
FDA 510(k) clearance K221653 · decided 2022-10-06
Clearance details
- K-number
- K221653
- Device name
- InfaTherm Disposable Infant Warming Mattress
- Applicant
- International Biomedical
- Decision
- Substantially Equivalent
- Date received
- 2022-06-07
- Decision date
- 2022-10-06
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- IMD
- Device class
- 1
- Regulation number
- 890.5710
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Infant Transport Mattress Warmer with Disc (K163295) | Rapid Aid Corp. | 2017-07-24 |
| NEO NEST (K112547) | Denovo Proucts, LLC | 2012-03-06 |
| EYEFEEL OPHTHALMIC WARMER (K082087) | Bio-Lipid, Inc. | 2008-09-11 |
| BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) (K071710) | Johnson & Johnson Consumer Products, Inc. | 2007-08-14 |
| EYEFEEL OPHTHALMIC WARMER (K021843) | Bio-Lipid, Inc. | 2002-09-03 |
| ALLEGIANCE PORTA-WARM MATTRESS (K982652) | Allegiance Healthcare Corp. | 1999-01-21 |
| DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS (K980509) | Deroyal Industries, Inc. | 1998-02-26 |
| CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER (K974190) | Consolidated Products & Services, Inc. | 1997-11-19 |
| ALLEGIANCE KWIK HEAT WARM PERINEAL PACK (K973770) | Allegiance Healthcare Corp. | 1997-11-13 |
| KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) (K970399) | Allegiance Healthcare Corp. | 1997-04-03 |
| RECOVER ADULT VEIN WARMER (K963689) | Florida Medical Industries, Inc. | 1996-12-12 |
| INSTANT HOT PACKS (K963768) | Kick Ice, Inc. | 1996-11-25 |
Recalls involving this device
No recalls on record reference this clearance.