# K991591: Biothane Patient Restraint

- Pathway: 510(k) (Traditional)
- Applicant: Bioplastics
- Decided: Jul 29, 1999 after 83 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
BioThane Patient Restraints are intended for medical purposes only. They are intended to limit the patient’s movements to the extent necessary for treatment, examination, or protection of the patient or others.

Source page: https://510kreport.com/device/K991591
Methodology: https://510kreport.com/methodology