InfaTherm Disposable Infant Warming Mattress— 510(k) K221653

Name: FDA 510(k) clearance K221653
Creator: U.S. Food and Drug Administration
Published: 2022-10-06

Substantially Equivalent

International Biomedical

FDA 510(k) clearance K221653 for InfaTherm Disposable Infant Warming Mattress, Substantially Equivalent on 2022-10-06. Applicant: International Biomedical. Device class: 1.

Clearance details

Applicant: International Biomedical
Product code: Code IMD
Device class: Class 1
Regulation: 21 CFR 890.5710
Advisory panel: Physical Medicine
Date received: 2022-06-07
Decision date: 2022-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IMD

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K163295 — Infant Transport Mattress Warmer with Disc2017-07-24
K112547 — NEO NEST2012-03-06
K082087 — EYEFEEL OPHTHALMIC WARMER2008-09-11
K071710 — BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)2007-08-14
K021843 — EYEFEEL OPHTHALMIC WARMER2002-09-03

More clearances from International Biomedical

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K221154 — Infant Heel WarmerTM; Heel Snuggler®2022-10-07
K220742 — NxtGen Infant Transport Incubator2022-07-15
K193481 — AeroNOx 2.0 Nitric Oxide Titration & Monitoring System2020-03-10
K182956 — Puffin Lite Infant Resuscitation System2019-01-18
K173516 — NuBorne Infant Warmer2018-08-17

Adverse events under product code IMD

product code IMD

Death: 3
Injury: 600
Total: 603

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.