Cleared Traditional

InfaTherm Disposable Infant Warming Mattress

K221653 · International Biomedical · Physical Medicine
Oct 2022
Decision
121d
Days
Class 1
Risk

About This 510(k) Submission

K221653 is an FDA 510(k) clearance for the InfaTherm Disposable Infant Warming Mattress, a Pack, Hot Or Cold, Disposable (Class I — General Controls, product code IMD), submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on October 6, 2022, 121 days after receiving the submission on June 7, 2022. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5710.

Submission Details

510(k) Number K221653 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2022
Decision Date October 06, 2022
Days to Decision 121 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IMD — Pack, Hot Or Cold, Disposable
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5710

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