Cleared Traditional

K914174 - STERILE DISPOSABLE WET SKIN SCRUB TRAY

K914174 is the FDA 510(k) clearance for STERILE DISPOSABLE WET SKIN SCRUB TRAY by Medical Device Inspection Co., Inc.. It is a Class 2 General & Plastic Surgery device (product code LRO) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K914174 · Medical Device Inspection Co., Inc. · General & Plastic Surgery device
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Feb 1992
Decision
159d
Days
Class 2
Risk

K914174 is an FDA 510(k) clearance for the STERILE DISPOSABLE WET SKIN SCRUB TRAY. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on February 24, 1992 after a review of 159 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 Medical Device Inspection Co., Inc. devices

Submission Details

510(k) Number K914174 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received September 18, 1991
Decision Date February 24, 1992
Days to Decision 159 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
44d slower than avg
Panel avg: 115d · This submission: 159d
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - LRO General Surgery Tray

All 28
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K914174.
MEDSURG O.R. PROCEDURE TRAY
K914037 · Medsurg Industries, Inc. · Jun 1993
PREP SHAVE KIT (NON-STERILE)
K925016 · Customed, Inc. · Apr 1993
MEDSURG LAPAROSCOPY TRAY
K914036 · Medsurg Industries, Inc. · Mar 1992
WOUND CLOSURE KIT
K910365 · Megadyne Medical Products, Inc. · Mar 1991
MEGA LACERATION KIT
K910368 · Megadyne Medical Products, Inc. · Mar 1991
CUSTOMED ARTHROSCOPY PACK
K902887 · Customed, Inc. · Sep 1990