Cleared Traditional

K935739 - SHAVE PREP TRAY

K935739 is an FDA 510(k) clearance for SHAVE PREP TRAY, manufactured by Cush Medical Products. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K935739 · Cush Medical Products · General Hospital
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Feb 1994
Decision
70d
Days
Class 2
Risk

K935739 is an FDA 510(k) clearance for the SHAVE PREP TRAY. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Cush Medical Products (Piney Flats, US). The FDA issued a Cleared decision on February 9, 1994 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cush Medical Products devices

FDA 510(k) Submission Details - K935739

510(k) Number K935739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1993
Decision Date February 09, 1994
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 172
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K935739.
AUTO SUTURE* STERILIZATION TRAY**
K954090 · United States Surgical, A Division of Tyco Healthc · Nov 1995
STERRAD STERILIZATION POUCH
K951295 · Advanced Sterilization Products · May 1995
BARRIER PLASTIC PACKAGING (MODIFICATION)
K933560 · Maxxim Medical · Apr 1994
THE KEYMED FIBERSCOPE STERILIZATION CASE
K860528 · Keymed, Inc. · Jul 1986
INSTRUMENT GUARD CAPSULE
K831588 · Treace Medical, Inc. · Jun 1983
DISPOSABLE INSTRUMENT TRAY PAD
K791412 · Anago, Inc. · Aug 1979