# K080448: Centurion Protective Restraint, SCR Series

- Pathway: 510(k) (Traditional)
- Applicant: Tri-State Hospital Supply Corp.
- Decided: Aug 28, 2008 after 191 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
Longest line of descent: 1 generation back to K963439 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963439: Pediatric Limb Holders, J. T. Posey Co. (1996) Summary page 1.

## Indications for use
The Centurion® Protective Restraint is a device, including a wristlet, anklet, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others. This device is intended for use on neonatal/newborn patients by or on the order of a physician in a hospital or clinic setting. The device is contraindicated for use on patients with dislocations, fractures, open wounds on the affected limb, or if I.V. site can be compromised.

Source page: https://510kreport.com/device/K080448
Methodology: https://510kreport.com/methodology