Cleared Traditional

DRESSING CHANGE TRAY (K935686) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 109
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K935686.
Medline General Surgery Tray
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PRESBYTERIAN LINEN SERVICES SURGICAL PACKS
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MEDLINE RADIOLOGY-DIAGNOSTIC KITS
K962826 · Medline Industries, Inc. · Sep 1996
E-Z PREP(R) TRAY WITH HIBICLENS(R)
K935483 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994
ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY
K934428 · Sherwood Medical Co. · Dec 1993