Cleared Traditional

K925216 - STERILE SKIN SCRUB TRAYS

K925216 is an FDA 510(k) clearance for STERILE SKIN SCRUB TRAYS, manufactured by American Healthcare Supply Co., Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K925216 · American Healthcare Supply Co., Inc. · General & Plastic Surgery device
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Jun 1993
Decision
249d
Days
Class 2
Risk

K925216 is an FDA 510(k) clearance for the STERILE SKIN SCRUB TRAYS. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by American Healthcare Supply Co., Inc. (South Plainfield, US). The FDA issued a Cleared decision on June 22, 1993 after a review of 249 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4370 - the FDA general and plastic surgery 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all American Healthcare Supply Co., Inc. devices

FDA 510(k) Submission Details - K925216

510(k) Number K925216 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received October 16, 1992
Decision Date June 22, 1993
Days to Decision 249 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 115d · This submission: 249d
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - LRO General Surgery Tray

All 55
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K925216.
STERILE INSTRUMENT TRAYS/BASIN SETS
K924468 · Baxter Healthcare Corp · Jul 1993
MEDLINES REPEAT PERFORMANCE SURGICAL PACK SYSTEM
K930700 · Medline Industries, Inc. · Jul 1993
MEDSURG O.R. PROCEDURE TRAY
K914037 · Medsurg Industries, Inc. · Jun 1993
PREP SHAVE KIT (NON-STERILE)
K925016 · Customed, Inc. · Apr 1993
DYONICS ARTHROSCOPIC KIT
K920267 · Smith & Nephew Dyonics, Inc. · Mar 1993
ACE CUSTOM SURGICAL PACK
K922648 · Ace Surgical Supply Co., Inc. · Mar 1993