Atlas FDA

FMS

27 FDA 510(k) clearances · Product code

83 daysmedian time to decision
483 days90th percentile
27clearances measured

FDA profile

Official device name
Bed, Pediatric Open Hospital
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5140
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 28 · 2022: 22 · 2023: 29 · 2024: 30 · 2025: 26 · 2026: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
NATURE'S CRADLE (K970334)Infant Advantage, Inc.1997-04-25
VAIL 100 PEDIATRIC CRIB (K963210)Vail Products, Inc.1996-11-13
NATURE'S CRADLE MODEL C1500 (K960747)Infant Advantage, Inc.1996-05-22
STRYKER ADEL BASSINET (K960012)Stryker Corp.1996-03-25
NATURE'S CRADLE (K951024)Infant Advantage, Inc.1995-06-05
MC HEALTHCARE #CH31 CHILD'S CRIB (K950058)Janco Consulting Services1995-02-10
MC INFANT CARE UNIE #PP30 (K950059)Janco Consulting Services1995-02-10
BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B (K950051)The Brewer Co.1995-02-10
INSTRUMENT WARMER (K925530)Superior Healthcare Group, Inc.1993-06-18
HEAD & FOOT END DROP PEDI-CRIB (K925817)Pedicraft, Inc.1993-04-20
PEDICRAGT BASSINET (K925949)Pedicraft, Inc.1993-04-20
NATURE'S CRADLE HM-10 (K921327)Infant Advantage, Inc.1992-12-29
NATURE'S CRADLE(TM) (K901763)Infant Advantage, Inc.1991-03-22
PEDIATRIC HOSPITAL BED (K900873)Hospital Supply Co., Inc.1990-05-18
MODIFIED REFLUX REDUCER (K883818)Physician Engineered Products, Inc.1988-11-21
BABYROCKER (K881019)Cinventa AB1988-06-07
BASSINET STAND WITH DRESSING TRAY (K880838)Serv-Queen, Inc.1988-04-29
CUDDLE CARRIER - INFANT BED (K845003)International Purchasing Services1986-04-23
CUDDLE HEART -AUDITORY/VIBRATION DEVICE (K845002)International Purchasing Services1986-04-23
CRIB CUDDLE - INFANT BED (K845004)International Purchasing Services1986-04-23
SWEET DREEMS SIMULATOR (K860596)Sweet Dreams, Inc.1986-03-06
NURSERY AMBIENT LIGHT METER (K860120)Rocky Mountain Medical Corp.1986-02-19
N.K. PEDIATRIC CRIBS (K853355)N.K. Medical Products, Inc.1985-09-20
MODEL 500 PEDIATRIC STRETCHER/CRIB (K852422)Midmark Corp.1985-07-05
MERIVAARA CRIB TROLLEY-MODEL 381 (K852173)Daun International, Inc.1985-06-17
PEDICRAFT BED, MODEL B2944 (K821773)Pedicraft, Inc.1982-06-23
TAB PEDIATRIC CRIB (K810728)Cambridge Scientific1981-04-03

Track FMS automatically

Every clearance here is in the API, with alerts when new ones post.