Cleared Traditional

K935686 - DRESSING CHANGE TRAY

K935686 is an FDA 510(k) clearance for DRESSING CHANGE TRAY, manufactured by Cush Medical Products. The device is a Class 2 General Hospital device with product code LRO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K935686 · Cush Medical Products · General Hospital
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Feb 1994
Decision
88d
Days
Class 2
Risk

K935686 is an FDA 510(k) clearance for the DRESSING CHANGE TRAY. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Cush Medical Products (Piney Flats, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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 - K935686

510(k) Number K935686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 29, 1993
Decision Date February 25, 1994
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRO Device Classification - Class 2, Special Controls

Product Code LRO General Surgery Tray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance
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 - LRO General Surgery Tray

All 42
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K935686.
WOUND CLOSURE/LACERATION TRAY
K950295 · Customed, Inc. · Apr 1995
INSTRUMENT TRAY
K935743 · Cush Medical Products · Mar 1994
CENTRAL LINE TRAY
K936117 · Cush Medical Products · Mar 1994
IRRIGATION TRAY
K935740 · Cush Medical Products · Feb 1994
MILL-ROSE PERCUTANEOUS PROCEDURAL KIT
K935858 · Mill-Rose Laboratory · Feb 1994
O.R. BASIN SET TRAY
K935741 · Cush Medical Products · Feb 1994