# K150243: Invictus Medical GelShield

- Pathway: 510(k) (Traditional)
- Applicant: Invictus Medical, Inc.
- Decided: May 1, 2015 after 88 days
- Product code: FMP (Protector, Skin Pressure)
- Device class: 1
- Regulation: 21 CFR 880.6450
- 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 K812344 (1981). 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)
- K812344: Heel or Elbow Protector, Fred Sammons, Inc. (1981) Summary page 4.

## Indications for use
The Invictus Medical, Inc. GelShield is a gel-filled positioning product that helps alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.

Source page: https://510kreport.com/device/K150243
Methodology: https://510kreport.com/methodology