Cleared Special

K140588 - FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS

K140588 is an FDA 510(k) clearance for FLYTE HYBRID HOOD, manufactured by Stryker Corporation. The device is a Class 2 General Hospital device with product code FXY cleared through the Special 510(k) pathway after a 111-day FDA review.

K140588 · Stryker Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
111d
Days
Class 2
Risk

K140588 is an FDA 510(k) clearance for the FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS. Classified as Hood, Surgical (product code FXY), Class II - Special Controls.

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on June 26, 2014 after a review of 111 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K140588

510(k) Number K140588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2014
Decision Date June 26, 2014
Days to Decision 111 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 129d · This submission: 111d
Pathway characteristics
Modification to existing cleared device.

FXY Device Classification - Class 2, Special Controls

Product Code FXY Hood, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FXY Hood, Surgical

All 10
Devices cleared under the same product code (FXY) and FDA review panel - the closest regulatory comparables to K140588.
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
K222214 · Thi Total Healthcare Innovation GmbH · Oct 2023
Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
K200493 · Stryker Corporation · Mar 2020
HOOD, OPERATING, SURGICAL
K904969 · Chicago Assoc. For Retarded Citizens · Dec 1990
DISPOSABLE BEARD COVER
K904276 · Anago, Inc. · Nov 1990
STERI-SHIELD
K903533 · Biomedical Devices, Inc. · Oct 1990
STERI-SHIELD
K902677 · Biomedical Devices, Inc. · Aug 1990
K140588 · FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
Download PDF FDA Summary Stryker Corporation