# K963466: Pediatric Limb Holder

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Feb 13, 1997 after 163 days
- Product code: FMQ (Restraint, Protective)
- Device class: 1
- Regulation: 21 CFR 880.6760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) J.T. Posey Company: named in the summary without a submission number
- (no number) DeRoyal Industries, Inc.: named in the summary without a submission number

## Indications for use
The DeRoyal Industries, Inc. Pediatric Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit pediatric patient limb movements thereby enabling examination or protection of the patient or others. The Pediatric Limb Holder can be used with an OR table, gurney, bed, or stretcher.

Source page: https://510kreport.com/device/K963466
Methodology: https://510kreport.com/methodology