Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

MPO — Predicate Candidate Screening

11 FDA 510(k) clearances under this product code; the 50 most recent screened below.

90 daysmedian FDA review time

255 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K221154	Infant Heel WarmerTM; Heel Snuggler®	International Biomedical	2022-10-07	169	0
K151845	Infant Heel Warmer (Model 24401) and WarmGel Infant Heel War	CooperSurgical, Inc.	2016-03-18	255	0
K150627	Rapid Aid Instant Disposable Infant Heel Warmer	Rapid Aid Corp.	2015-05-27	77	0
K103549	DENOVO TEDDY GEL INFANT HEEL WARMER	Denovo Products, LLC	2011-04-08	126	0
K053254	INFANT HEEL WARMER BY INTCO	Shanghai Intco Medical Supply Co., Ltd.	2006-09-19	302	0
K040856	RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER	Rapid Aid , Ltd.	2004-05-03	31	0
K040044	HEEL SNUGGLER, MODEL 99047	Respironics, Inc.	2004-01-27	15	1
K032989	MEDI-HEAT INFANT HEEL WARMER	Mediheat, Inc.	2003-10-22	28	0
K964523	RECOVER INFANT HEEL WARMER (5100)	Florida Medical Industries, Inc.	1997-02-10	90	2
K961154	BAXTER SODIUM ACETATE INFANT HEEL WARMER	Baxter Healthcare Corp	1996-06-06	76	1
K954716	DEROYAL INDUSTRIES INFANT HEEL WARMER	Debusk Knitting Mills, Div. Deroyal Industries	1996-01-11	90	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda