Cleared Traditional

K832137 - CONVERTORS FLASH STERILIZING TRAY

K832137 is an FDA 510(k) clearance for CONVERTORS FLASH STERILIZING TRAY, manufactured by American Convertors Div., American Pharmaseal. The device is a Class 1 General & Plastic Surgery device with product code FSM cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K832137 · American Convertors Div., American Pharmaseal · General & Plastic Surgery device
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Aug 1983
Decision
42d
Days
Class 1
Risk

K832137 is an FDA 510(k) clearance for the CONVERTORS FLASH STERILIZING TRAY. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by American Convertors Div., American Pharmaseal (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 42 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Convertors Div., American Pharmaseal devices

FDA 510(k) Submission Details - K832137

510(k) Number K832137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1983
Decision Date August 12, 1983
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
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 38
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K832137.
STERILE INSTRUMENT TRAYS-VARIOUS
K843723 · E.M. Adams · Oct 1984
VARIOUS DISPOSABLE KITS/TRAYS/INSTRU
K840976 · Carapace, Inc. · May 1984
TRACHEOSTOMY CARE TRAY
K841122 · Medcare Products · Apr 1984
MEDCARE SUTURE REMOVAL TRAYS
K823854 · Medcare Products · Mar 1983
HANDI-TRAY
K823438 · Treace Medical, Inc. · Jan 1983
MEDCARE WOUND CLOSURE TRAY
K823853 · Medcare Products · Jan 1983