Crib Cuddle - Infant Bed
by International Purchasing Services 510(k)
Active
510(k) K845004
Overview
The Crib Cuddle - Infant Bed is a Bed, Pediatric Open Hospital device as defined by its classification name and medical specialty description. It is a pediatric open hospital bed designed for use in general hospital settings.
The device received FDA 510(k) clearance under K845004 on April 23, 1986, with a substantially equivalent decision. It is classified as a Class II medical device under regulation number 880.5140 and product code FMS, and is manufactured by International Purchasing Services.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK845004 | Date23 Apr 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FMS
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5140
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from International Purchasing Services
Questions
What is the Crib Cuddle - Infant Bed used for?
The Crib Cuddle - Infant Bed is a pediatric open hospital bed designed for use in general hospital settings to support infant care, providing a safe and accessible sleeping environment for neonates and young children during hospitalization.
How is the Crib Cuddle - Infant Bed supplied and is it reusable?
The device is supplied as a reusable pediatric open hospital bed intended for multiple patient use after proper cleaning and disinfection between uses, consistent with standard hospital bed protocols for infection control in general hospital environments.
What regulatory clearance does the Crib Cuddle - Infant Bed have?
The Crib Cuddle - Infant Bed received FDA 510(k) clearance under K845004 on April 23, 1986, with a substantially equivalent determination, and is classified as a Class II medical device under product code FMS and regulation 880.5140.