# K140588: Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway Lens

- Pathway: 510(k) (Special)
- Applicant: Stryker Corporation
- Decided: Jun 26, 2014 after 111 days
- Product code: FXY (Hood, 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: 3 generations back to K944393 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063005: Stryker T6 Hoods and Togas, Stryker Instruments (2007) Summary page 1.

## Indications for use
The Stryker Flyte Hybrid Hoods are components of a personal protection system and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material. The devices are provided sterile and for single use only.

Source page: https://510kreport.com/device/K140588
Methodology: https://510kreport.com/methodology