Cleared Traditional

K811916 - OPERATING ROOM KIT

K811916 is the FDA 510(k) clearance for OPERATING ROOM KIT by American Hospital Supply Corp.. It is a Class 1 General & Plastic Surgery device (product code FSM) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K811916 · American Hospital Supply Corp. · General & Plastic Surgery device
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Oct 1981
Decision
105d
Days
Class 1
Risk

K811916 is an FDA 510(k) clearance for the OPERATING ROOM KIT. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on October 14, 1981 after a review of 105 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 Hospital Supply Corp. devices

Submission Details

510(k) Number K811916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1981
Decision Date October 14, 1981
Days to Decision 105 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 115d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FSM Tray, Surgical, Instrument
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 - FSM Tray, Surgical, Instrument

All 9
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K811916.
HANDI-TRAY
K823438 · Treace Medical, Inc. · Jan 1983
AUXILIARY TRAY
K802088 · American Pharmaseal Div. Ahsc · Nov 1980
CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI
K801964 · American Pharmaseal Div. Ahsc · Oct 1980
CUSTOM UNIVERSAL CUTDOWN PREP TRAY
K801965 · American Pharmaseal Div. Ahsc · Oct 1980
MICRO CLIP STERILIZING CASE #65199
K801470 · Edward Weck, Inc. · Jul 1980
MICRESURGICAL TRAY, SM.,MED., & LG.
K800367 · Edward Weck, Inc. · Mar 1980