# K981115: Radio-Plast

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 25, 1998 after 90 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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 K933227 (1994). 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)
- K933227: Uni-Frame Head Immobilization System, Medtec, Inc. (1994) Summary page 1.
- (no number) Aquaplast thermoplastic: named in the summary without a submission number

## Indications for use
These low temperature thermoplastic sheets may be used to fabricate custom positioning and immobilization devices for radiation therapy. These sheets may be formed directly against the patient's skin to produce immobilizer for any part of the body. The immobilizer should be used any time precise, repeatable positioning of a patient is required.

Source page: https://510kreport.com/device/K981115
Methodology: https://510kreport.com/methodology