FMS · Bed, Pediatric Open Hospital
General Hospital · 21 CFR 880.5140 · Class 2
Overview
| Product Code | FMS |
|---|---|
| Device Name | Bed, Pediatric Open Hospital |
| Regulation | 21 CFR 880.5140 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A pediatric medical crib is a prescription device intended for medical purposes for use with a pediatric patient that consists of an open crib, fixed end rails, movable and latchable side rail components, and possibly an accompanying mattress. The contour of the crib surface may be adjustable.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9. The special controls for this device are:
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9. The special controls for this device are:(1) Crib design and performance testing shall demonstrate the mechanical and structural stability of the crib under expected conditions of use, including the security of latches and other locking mechanisms when engaged; (2) Materials used shall be appropriate for the conditions of use, allow for proper sanitation, and be free from surface defects that could result in injuries; (3) The height of the rail and end panel as measured from the top of the rail or panel in its highest position to the top of the mattress support in its lowest position shall be at least 26 inches (66 centimeters). Any mattress used in this crib must not exceed a thickness of 6 inches; (4) Hardware and fasteners shall be designed and constructed to eliminate mechanical hazards to the patient; (5) The distance between components of the side rail ( *i.e.,* slats, spindles, and corner posts) shall not be greater than 23/8 inches (6 centimeters) apart at any point;(6) The mattress must fit tightly around all four sides of the crib base, such that entrapment or impingement of occupant is prevented; (7) The mattress for the crib shall meet the Consumer Product Safety Commission (CPSC) Standard for the flammability of mattresses and mattress pads (FF 4-72, amended) and Standard for the flammability (open flame) of mattress sets, 16 CFR parts 1632 and 1633, respectively; and (8) Each device must have the following label(s) affixed: (i) Adequate instructions for users to care for, maintain, and clean the crib; and (ii) A warning label on at least two sides of the medical crib with the following language in text of at least 9 millimeters in height: WARNING: Never leave a child unsupervised when the moveable side is open or not secured.
Recent Cleared Devices (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K970334 | NATURE'S CRADLE | Infant Advantage, Inc. | Apr 25, 1997 | SESE |
| K963210 | VAIL 100 PEDIATRIC CRIB | Vail Products, Inc. | Nov 13, 1996 | SESE |
| K960747 | NATURE'S CRADLE MODEL C1500 | Infant Advantage, Inc. | May 22, 1996 | SESE |
| K960012 | STRYKER ADEL BASSINET | Stryker Corp. | Mar 25, 1996 | SESE |
| K951024 | NATURE'S CRADLE | Infant Advantage, Inc. | Jun 5, 1995 | SESE |
| K950059 | MC INFANT CARE UNIE #PP30 | Janco Consulting Services | Feb 10, 1995 | SESE |
| K950058 | MC HEALTHCARE #CH31 CHILD'S CRIB | Janco Consulting Services | Feb 10, 1995 | SESE |
| K950051 | BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B | The Brewer Co. | Feb 10, 1995 | SESE |
| K925530 | INSTRUMENT WARMER | Superior Healthcare Group, Inc. | Jun 18, 1993 | SESE |
| K925949 | PEDICRAGT BASSINET | Pedicraft, Inc. | Apr 20, 1993 | SESE |
| K925817 | HEAD & FOOT END DROP PEDI-CRIB | Pedicraft, Inc. | Apr 20, 1993 | SESE |
| K921327 | NATURE'S CRADLE HM-10 | Infant Advantage, Inc. | Dec 29, 1992 | SESE |
| K901763 | NATURE'S CRADLE(TM) | Infant Advantage, Inc. | Mar 22, 1991 | SESE |
| K900873 | PEDIATRIC HOSPITAL BED | Hospital Supply Co., Inc. | May 18, 1990 | SESE |
| K883818 | MODIFIED REFLUX REDUCER | Physician Engineered Products, Inc. | Nov 21, 1988 | SESE |
| K881019 | BABYROCKER | Cinventa AB | Jun 7, 1988 | SESE |
| K880838 | BASSINET STAND WITH DRESSING TRAY | Serv-Queen, Inc. | Apr 29, 1988 | SESE |
| K845004 | CRIB CUDDLE - INFANT BED | International Purchasing Services | Apr 23, 1986 | SESE |
| K845003 | CUDDLE CARRIER - INFANT BED | International Purchasing Services | Apr 23, 1986 | SESE |
| K845002 | CUDDLE HEART -AUDITORY/VIBRATION DEVICE | International Purchasing Services | Apr 23, 1986 | SESE |
Top Applicants
- Infant Advantage, Inc. — 5 clearances
- International Purchasing Services — 3 clearances
- Pedicraft, Inc. — 3 clearances
- Janco Consulting Services — 2 clearances
- Cambridge Scientific — 1 clearance
