InfaTherm Disposable Infant Warming Mattress
FDA 510(k) K221653 · International Biomedical
510(k) numberK221653
Submission
- Device name
- InfaTherm Disposable Infant Warming Mattress
- Applicant
- International Biomedical
Austin, TX, US - Received
- June 7, 2022
- Decision date
- October 6, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IMD – Pack, Hot Or Cold, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5710
- Specialty
- Physical Medicine
Other 510(k)s with product code IMD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K163295 | Infant Transport Mattress Warmer with DiscIMD · Traditional | Rapid Aid Corp. | 07/24/2017SE |
| K112547 | Neo NestIMD · Traditional | Denovo Proucts, LLC | 03/06/2012SE |
| K082087 | Eyefeel Ophthalmic WarmerIMD · Traditional | Bio-Lipid, Inc. | 09/11/2008SE |
| K071710 | Bengay (R) Heat Therapy, Pain Relieving Patches/Pads (Various)IMD · Traditional | Johnson & Johnson Consumer Products, Inc. | 08/14/2007SE |
| K021843 | Eyefeel Ophthalmic WarmerIMD · Traditional | Bio-Lipid, Inc. | 09/03/2002SE |
| K982652 | Allegiance Porta-Warm MattressIMD · Traditional | Allegiance Healthcare Corp. | 01/21/1999SE |
| K980509 | Deroyal Industries, Inc. Infant Transport MattressIMD · Traditional | Deroyal Industries, Inc. | 02/26/1998SE |
| K974190 | Cp&S Instant Cold Pack Limb Kit TransporterIMD · Traditional | Consolidated Products & Services, Inc. | 11/19/1997SE |
| K973770 | Allegiance Kwik Heat Warm Perineal PackIMD · Traditional | Allegiance Healthcare Corp. | 11/13/1997SE |
| K970399 | Kwik Kold Peri Cold Pack (Catalog Number TBD)IMD · Traditional | Allegiance Healthcare Corp. | 04/03/1997SE |
More from Allegiance Healthcare Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K221154 | Infant Heel WarmerTM; Heel Snuggler®MPO · Traditional | 10/07/2022SE |
| K220742 | NxtGen Infant Transport IncubatorFPL · Traditional | 07/15/2022SE |
| K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring SystemMRN · Special | 03/10/2020SE |
| K182956 | Puffin Lite Infant Resuscitation SystemBTL · Special | 01/18/2019SE |
| K173516 | NuBorne Infant WarmerFMT · Abbreviated | 08/17/2018SE |
| K160238 | Airborne Phototherapy LightLBI · Abbreviated | 06/14/2016SE |
| K140707 | Lifeborne Infant ResuscitatorBTL · Traditional | 05/28/2014SE |
| K103525 | A750I Transport Incubator with Masimo Pluseox, A750I Transport Incubator with Nellor…FPL · Special | 05/11/2011SE |
| K103523 | 185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport Incubator with Nellcor…FPL · Special | 05/11/2011SE |
| K103527 | Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator with…FPL · Special | 04/15/2011SE |
Questions and answers
When was InfaTherm Disposable Infant Warming Mattress cleared by the FDA?
InfaTherm Disposable Infant Warming Mattress (K221653) received a 510(k) decision of Substantially Equivalent on October 6, 2022, 121 days after the submission was received.
What is the product code of K221653?
The FDA product code is IMD – Pack, Hot Or Cold, Disposable, a Class I (low risk) device regulated under 21 CFR 890.5710.