Cleared Traditional

K843561 - MSI SURGI-GRADE UNIVERSAL TRACH TRAY

K843561 is an FDA 510(k) clearance for MSI SURGI-GRADE UNIVERSAL TRACH TRAY, manufactured by Medical Sterilization, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FSM cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K843561 · Medical Sterilization, Inc. · General & Plastic Surgery device
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Oct 1984
Decision
44d
Days
Class 1
Risk

K843561 is an FDA 510(k) clearance for the MSI SURGI-GRADE UNIVERSAL TRACH TRAY. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by Medical Sterilization, Inc.. The FDA issued a Cleared decision on October 24, 1984 after a review of 44 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.

FDA 510(k) Submission Details - K843561

510(k) Number K843561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1984
Decision Date October 24, 1984
Days to Decision 44 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
71d faster than avg
Panel avg: 115d · This submission: 44d
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 75
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K843561.
FLASH GUARD PLASTIC VERSION
K844286 · Sparco, Inc. · Nov 1984
HU-FRIEDY IMS CASSETTE SYSTEM
K844002 · Hu-Friedy Mfg. Co., Inc. · Nov 1984
MSI SURGI-GRADE SUTURE TRAY
K843564 · Medical Sterilization, Inc. · Oct 1984
ABDOMINAL PARACENTESIS TRAY
K842009 · Jayco Pharmaceuticals · Oct 1984
MSI SURGI-GRADE INCISION & DRAIN TRAY
K843563 · Medical Sterilization, Inc. · Oct 1984
STERILE INSTRUMENT TRAYS-VARIOUS
K843723 · E.M. Adams · Oct 1984
K843561 · MSI SURGI-GRADE UNIVERSAL TRACH TRAY
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