# K994053: Stryker T4 Power Pack, Stryker T4 Eight Station Battery Charger, Stryker T4 Charger Module

- Pathway: 510(k) (Special)
- Applicant: Stryker Instruments
- Decided: Dec 20, 1999 after 20 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- 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
The Stryker T4 Powerpack and Accessories are components of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

Source page: https://510kreport.com/device/K994053
Methodology: https://510kreport.com/methodology