# K990079: Fastseal Chest Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Greenfield Medical Technologies, Inc.
- Decided: Dec 23, 1999 after 346 days
- Product code: MGP (Dressing, Wound And Burn, Occlusive)
- Device class: U
- 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
1. To be used as a temporary bandage to treat penetrating chest wounds that could corapromise the pleural space of the chest cavity, such as: gunshot wounds, stab wounds and fragment wounds. 2. To be used on a temporary and emergency basis in the management of an open preumothorax condition. 3. To prevent a tension pneumothorax, and /or reinflate a collapsed lung without using invasive procedures.

Source page: https://510kreport.com/device/K990079
Methodology: https://510kreport.com/methodology