Cleared Traditional

K812133 - WOUND CLOSURE INSTRUMENT TRAY

K812133 is an FDA 510(k) clearance for WOUND CLOSURE INSTRUMENT TRAY, manufactured by E.M. Adams. The device is a Class 1 General & Plastic Surgery device with product code FSM cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K812133 · E.M. Adams · General & Plastic Surgery device
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Jan 1982
Decision
164d
Days
Class 1
Risk

K812133 is an FDA 510(k) clearance for the WOUND CLOSURE INSTRUMENT TRAY. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by E.M. Adams (Mchenry, US). The FDA issued a Cleared decision on January 8, 1982 after a review of 164 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 E.M. Adams devices

FDA 510(k) Submission Details - K812133

510(k) Number K812133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1981
Decision Date January 08, 1982
Days to Decision 164 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
49d slower than avg
Panel avg: 115d · This submission: 164d
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 25
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K812133.
STERILE INSTRUMENT TRAYS-VARIOUS
K843723 · E.M. Adams · Oct 1984
VARIOUS DISPOSABLE KITS/TRAYS/INSTRU
K840976 · Carapace, Inc. · May 1984
HANDI-TRAY
K823438 · Treace Medical, Inc. · Jan 1983
OPERATING ROOM KIT
K811916 · American Hospital Supply Corp. · Oct 1981
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