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FDA 510(k)

Infant Heel WarmerTM; Heel Snuggler®

K-Number: K221154 · 2022-10-07

ApplicantInternational Biomedical
Decision Date2022-10-07
Product CodeMPO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Infant Heel WarmerTM; Heel Snuggler® is the device name listed in this FDA 510(k) record. The listed applicant is International Biomedical. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K221154. The device is classified under product code MPO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Infant Heel WarmerTM; Heel Snuggler®?

Infant Heel WarmerTM; Heel Snuggler® is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is International Biomedical. The 510(k) number is K221154.

When did Infant Heel WarmerTM; Heel Snuggler® receive FDA 510(k) clearance?

Infant Heel WarmerTM; Heel Snuggler® received FDA 510(k) clearance on 2022-10-07, under 510(k) number K221154.

Who is the listed applicant for Infant Heel WarmerTM; Heel Snuggler®?

The FDA 510(k) record lists International Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infant Heel WarmerTM; Heel Snuggler®?

The FDA product code for Infant Heel WarmerTM; Heel Snuggler® is MPO.

Other records listing International Biomedical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MPO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)CooperSurgical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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