Product Code: FMS FDA class 2 21 CFR 880.5140

Bed, Pediatric Open Hospital

General Hospital

The Pediatric Open Hospital Bed is a crib-style or open-sided hospital bed designed for use with infant and pediatric patients, providing a safe and accessible care surface in a clinical setting. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FMS, regulated under 21 CFR 880.5140 in the General Hospital specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FMS
Device Class: FDA class 2
Regulation Number: 880.5140
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

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