Cleared Traditional

K924725 - AMERICAN BIOMED

K924725 is an FDA 510(k) clearance for AMERICAN BIOMED, manufactured by American Biomaterials Corp.. The device is a Class 1 General & Plastic Surgery device with product code MDM cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K924725 · American Biomaterials Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
137d
Days
Class 1
Risk

K924725 is an FDA 510(k) clearance for the AMERICAN BIOMED, INC. MICROSURGICAL INSTRUMENTS. Classified as Instrument, Manual, Surgical, General Use (product code MDM), Class I - General Controls.

Submitted by American Biomaterials Corp. (The Woodlands, US). The FDA issued a Cleared decision on February 5, 1993 after a review of 137 days - within the typical 510(k) review window.

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 Biomaterials Corp. devices

FDA 510(k) Submission Details - K924725

510(k) Number K924725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1992
Decision Date February 05, 1993
Days to Decision 137 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 115d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

MDM Device Classification - Class 1, General Controls

Product Code MDM Instrument, Manual, Surgical, General Use
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 - MDM Instrument, Manual, Surgical, General Use

All 7
Devices cleared under the same product code (MDM) and FDA review panel - the closest regulatory comparables to K924725.
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