Cleared Traditional

K925215 - STERILE SURGICAL INSTRUMENT TRAYS

K925215 is an FDA 510(k) clearance for STERILE SURGICAL INSTRUMENT TRAYS, manufactured by American Healthcare Supply Co., Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K925215 · American Healthcare Supply Co., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
228d
Days
Class 1
Risk

K925215 is an FDA 510(k) clearance for the STERILE SURGICAL INSTRUMENT TRAYS. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by American Healthcare Supply Co., Inc. (South Plainfield, US). The FDA issued a Cleared decision on June 1, 1993 after a review of 228 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 - K925215

510(k) Number K925215 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received October 16, 1992
Decision Date June 01, 1993
Days to Decision 228 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
113d slower than avg
Panel avg: 115d · This submission: 228d
Pathway characteristics
Predicate-based equivalence.

KDD Device Classification - Class 1, General Controls

Product Code KDD Kit, Surgical Instrument, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KDD Kit, Surgical Instrument, Disposable

All 26
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K925215.
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
K072814 · Covidien · Apr 2008
SUTURE SET OR LACERATION TRAYS (PACKS)
K932219 · Associated Medical Products Co. · Jul 1993
SURGICAL INSTRUMENT KIT, DISPOSABLE
K923176 · Ulti-Med Intl., Inc. · Jun 1993
DEXIDE LAPAROSCOPIC KITS
K924117 · Dexide, Inc. · Mar 1993
SURGICAL INSTRUMENT KIT, DISPOSABLE
K920989 · Ulti-Med Intl., Inc. · Oct 1992
GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB
K920516 · Trinity Laboratories, Inc. · Apr 1992