# K192194: TotalShield II Surgical Helmet System

- Pathway: 510(k) (Special)
- Applicant: Zimmer Surgical, Inc.
- Decided: Oct 15, 2019 after 63 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K243522: ViVi® Toga Premium (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K192194
Methodology: https://510kreport.com/methodology