Cleared Traditional

K925016 - PREP SHAVE KIT (NON-STERILE)

K925016 is an FDA 510(k) clearance for PREP SHAVE KIT (NON-STERILE), manufactured by Customed, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K925016 · Customed, Inc. · General & Plastic Surgery device
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Apr 1993
Decision
214d
Days
Class 2
Risk

K925016 is an FDA 510(k) clearance for the PREP SHAVE KIT (NON-STERILE). Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on April 26, 1993 after a review of 214 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 Customed, Inc. devices

FDA 510(k) Submission Details - K925016

510(k) Number K925016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1992
Decision Date April 26, 1993
Days to Decision 214 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 115d · This submission: 214d
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 K925016.
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
DYONICS ARTHROSCOPIC KIT
K920267 · Smith & Nephew Dyonics, Inc. · Mar 1993
ACE CUSTOM SURGICAL PACK
K922648 · Ace Surgical Supply Co., Inc. · Mar 1993
MEDSURG LAPAROSCOPY TRAY
K914036 · Medsurg Industries, Inc. · Mar 1992