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

FMS — Predicate Candidate Screening

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

83 daysmedian FDA review time

483 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days
K970334	NATURE'S CRADLE	Infant Advantage, Inc.	1997-04-25	87
K963210	VAIL 100 PEDIATRIC CRIB	Vail Products, Inc.	1996-11-13	89
K960747	NATURE'S CRADLE MODEL C1500	Infant Advantage, Inc.	1996-05-22	89
K960012	STRYKER ADEL BASSINET	Stryker Corp.	1996-03-25	83
K951024	NATURE'S CRADLE	Infant Advantage, Inc.	1995-06-05	91
K950058	MC HEALTHCARE #CH31 CHILD'S CRIB	Janco Consulting Services	1995-02-10	35
K950059	MC INFANT CARE UNIE #PP30	Janco Consulting Services	1995-02-10	35
K950051	BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B	The Brewer Co.	1995-02-10	35
K925530	INSTRUMENT WARMER	Superior Healthcare Group, Inc.	1993-06-18	228
K925817	HEAD & FOOT END DROP PEDI-CRIB	Pedicraft, Inc.	1993-04-20	154
K925949	PEDICRAGT BASSINET	Pedicraft, Inc.	1993-04-20	147
K921327	NATURE'S CRADLE HM-10	Infant Advantage, Inc.	1992-12-29	286
K901763	NATURE'S CRADLE(TM)	Infant Advantage, Inc.	1991-03-22	338
K900873	PEDIATRIC HOSPITAL BED	Hospital Supply Co., Inc.	1990-05-18	81
K883818	MODIFIED REFLUX REDUCER	Physician Engineered Products, Inc.	1988-11-21	74
K881019	BABYROCKER	Cinventa AB	1988-06-07	89
K880838	BASSINET STAND WITH DRESSING TRAY	Serv-Queen, Inc.	1988-04-29	59
K845003	CUDDLE CARRIER - INFANT BED	International Purchasing Services	1986-04-23	483
K845002	CUDDLE HEART -AUDITORY/VIBRATION DEVICE	International Purchasing Services	1986-04-23	483
K845004	CRIB CUDDLE - INFANT BED	International Purchasing Services	1986-04-23	483
K860596	SWEET DREEMS SIMULATOR	Sweet Dreams, Inc.	1986-03-06	15
K860120	NURSERY AMBIENT LIGHT METER	Rocky Mountain Medical Corp.	1986-02-19	37
K853355	N.K. PEDIATRIC CRIBS	N.K. Medical Products, Inc.	1985-09-20	39
K852422	MODEL 500 PEDIATRIC STRETCHER/CRIB	Midmark Corp.	1985-07-05	28
K852173	MERIVAARA CRIB TROLLEY-MODEL 381	Daun International, Inc.	1985-06-17	28
K821773	PEDICRAFT BED, MODEL B2944	Pedicraft, Inc.	1982-06-23	7
K810728	TAB PEDIATRIC CRIB	Cambridge Scientific	1981-04-03	17

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