Cleared Traditional

K935742 - SKIN SCRUB TRAY

K935742 is an FDA 510(k) clearance for SKIN SCRUB TRAY, manufactured by Cush Medical Products. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K935742 · Cush Medical Products · General Hospital
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Feb 1994
Decision
71d
Days
Class 2
Risk

K935742 is an FDA 510(k) clearance for the SKIN SCRUB TRAY. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Cush Medical Products (Piney Flats, US). The FDA issued a Cleared decision on February 10, 1994 after a review of 71 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 - K935742

510(k) Number K935742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1993
Decision Date February 10, 1994
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
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 - FRG Wrap, Sterilization

All 148
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K935742.
LACERATION TRAY
K935682 · Cush Medical Products · Feb 1994
SUTURE REMOVAL TRAY
K935683 · Cush Medical Products · Feb 1994
TRACHEOSTOMY CARE TRAY
K935685 · Cush Medical Products · Feb 1994
WRAPPEL T
K923408 · Standard Textile Co., Inc. · Apr 1993
CONVERTORS STERILIZATION WRAP
K921243 · Baxter Healthcare Corp · Oct 1992
DRESSING CHANG & WOUND MANAGEMENT
K920480 · Cypress Medical Products, Ltd. · Oct 1992