Head & Foot End Drop Pedi-Crib
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K925817 FDA 510(k)
- FDA Product Code
- FMS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5140 FDA 510(k)
- Regulation Number
- 880.5140 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Head & Foot End Drop Pediatric Crib is a pediatric bed designed for hospital use, featuring adjustable side rails and drop-down end panels for improved patient access and care. It is classified as a Class II medical device under FDA regulations, intended for use in general hospital settings to provide safe and secure patient positioning in pediatric care environments.
This device is supplied in two sizes: 35x60 inches and 35x76 inches, with an optional head elevation feature adjustable to a 30-degree angle via hand crank. It is intended for single-use or reusable applications in hospital settings, with no specific sterility requirements noted in the regulatory data. The device holds an FDA 510(k) clearance (K925817) under the classification FMS, with no additional regulatory markings or MRI safety considerations mentioned.
Frequently asked questions
What sizes are available for the Head & Foot End Drop Pediatric Crib, and how does the optional head elevation feature work?
The Head & Foot End Drop Pediatric Crib comes in two standard sizes: 35x60 inches and 35x76 inches. The optional head elevation feature allows the head section to be adjusted up to a 30-degree angle using a hand crank, which helps improve patient positioning and access for care providers.
Is this pediatric crib intended for single-use or reusable applications in a hospital setting?
The device is designed for use in hospital settings with flexibility for either single-use or reusable applications, though no specific sterility requirements are mentioned in the regulatory data. Hospitals may follow their own protocols for cleaning and reprocessing if reusing.
How do I determine if this crib is compatible with my hospital’s existing pediatric care workflows?
This crib is classified under FDA’s General Hospital advisory committee and holds a 510(k) clearance (K925817) for pediatric bed use, meaning it’s intended for standard hospital environments where safe, adjustable patient positioning is required. Its adjustable side rails and drop-down end panels are designed to enhance accessibility and care, making it suitable for general pediatric care settings.
Are there any special storage or handling instructions for this pediatric crib?
The regulatory data does not specify special storage requirements beyond typical hospital equipment handling. Since it’s designed for reusable applications, ensure proper cleaning and maintenance per your facility’s protocols. The crib’s adjustable features (like the head elevation) may require occasional lubrication or inspection to maintain functionality.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HEAD & FOOT END DROP PEDI-CRIB (K925817) — FDA 510 (k) | Innolitics, HEAD & FOOT END DROP PEDI-CRIB 510 (k) K925817 - FDA.report, PDF Pedi-Crib Bed - pedicraft.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K925817 | Class II | Active |
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Manufacturer
- Manufacturer
- Pedicraft, Inc.
Sources (1)
- FDA 510(k) K925817 24 fields · synced Sep 19, 2026