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FDA 510(k)

Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)

K-Number: K151845 · 2016-03-18

ApplicantCooperSurgical, Inc.
Decision Date2016-03-18
Product CodeMPO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) is a medical device manufactured by CooperSurgical, Inc.. It received FDA 510(k) clearance on 2016-03-18 under approval number K151845. 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 Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)?

Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) is a medical device that received FDA 510(k) clearance on 2016-03-18. It is manufactured by CooperSurgical, Inc.. The 510(k) number is K151845.

When was Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) approved by the FDA?

Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) received FDA 510(k) clearance on 2016-03-18, under approval number K151845.

What company makes Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)?

Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) is manufactured by CooperSurgical, Inc..

What is the FDA product code for Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)?

The FDA product code for Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) is MPO.

Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026)

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Related Devices (Code: MPO)

K221154Infant Heel WarmerTM; Heel Snuggler®International Biomedical

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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