# K040485: Maxair Surgical Helmet System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Medical Devices, Inc.
- Decided: Oct 18, 2004 after 236 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K993148 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993148: Stryker T4 Hood, Stryker T4 Zippered Toga, Stryker T4 Pullover Toga, Stryker Instruments (1999) Summary page 1.

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0835-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed

## Indications for use
The MAXair Surgical Helmet system is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The MAXair Surgical Helmet system consists of disposable surgical apparel and re-usable headgear, battery pack and accessory battery charger.

Source page: https://510kreport.com/device/K040485
Methodology: https://510kreport.com/methodology