# K132386: Totalshield Surgical Helmet System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Dec 23, 2013 after 144 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
Longest line of descent: 1 generation back to K102971 (2011). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102971: Freedomaire Iii Surgical Helmet System Model 10322STK, Microtek Medical, Inc. (2011) Summary page 1.

## Most influential descendants
- K222214: ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) (2023), 0 descendants of its own
- K142166: Total Shield Surgical;Toga (Regular, Large,X-Large);Hood; Helmet Advanced Helmet W/Led Lighting, Total Shield Accessories (2014), 0 descendants of its own

## Indications for use
The TotalShield Zippered Surgical Toga and/or TotalShield Surgical Hood is for use with the TotalShield Surgical Helmet and/or TotalShield Advanced Surgical Helmet with LED lighting as TotalShield Surgical Helmet System that is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

Source page: https://510kreport.com/device/K132386
Methodology: https://510kreport.com/methodology