Cleared Traditional

K811916 - OPERATING ROOM KIT

K811916 is an FDA 510(k) clearance for OPERATING ROOM KIT, manufactured by American Hospital Supply Corp.. The device is a Class 1 General & Plastic Surgery device with 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

FDA 510(k) Submission Details - K811916

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 115d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

FSM Device Classification - Class 1, General Controls

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 37
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K811916.
MEDCARE GENERAL PURPOSE TRAY
K823856 · Medcare Products · Jan 1983
INCISION & DRAINAGE TRAY
K812134 · E.M. Adams · Jan 1982
WOUND CLOSURE INSTRUMENT TRAY
K812133 · E.M. Adams · Jan 1982
AMPCO-DRESSING CHANGE TRAY-MAJOR DC
K802964 · Associated Medical Products Co. · Jan 1981
AMPCO-DRESSING CHANGE TRAY-MAJOR DC 7418
K802965 · Associated Medical Products Co. · Jan 1981
AUXILIARY TRAY
K802088 · American Pharmaseal Div. Ahsc · Nov 1980