# K102971: Freedomaire Iii Surgical Helmet System Model 10322STK

- Pathway: 510(k) (Traditional)
- Applicant: Microtek Medical, Inc.
- Decided: Feb 23, 2011 after 140 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.
3 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K132386: Totalshield Surgical Helmet System (2013), 2 descendants of its own
- 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 Freedomaire III Surgical Helmet System 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/K102971
Methodology: https://510kreport.com/methodology