Cleared Traditional

K913643 - MUCOUS SPECIMEN TRAP

K913643 is an FDA 510(k) clearance for MUCOUS SPECIMEN TRAP, manufactured by Medical Device Inspection Co., Inc.. The device is a Class 2 General Hospital device with product code BYZ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K913643 · Medical Device Inspection Co., Inc. · General Hospital
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Oct 1991
Decision
57d
Days
Class 2
Risk

K913643 is an FDA 510(k) clearance for the MUCOUS SPECIMEN TRAP. Classified as Trap, Sterile Specimen (product code BYZ), Class II - Special Controls.

Submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on October 10, 1991 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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 - K913643

510(k) Number K913643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1991
Decision Date October 10, 1991
Days to Decision 57 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 129d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYZ Device Classification - Class 2, Special Controls

Product Code BYZ Trap, Sterile Specimen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - BYZ Trap, Sterile Specimen

All 8
Devices cleared under the same product code (BYZ) and FDA review panel - the closest regulatory comparables to K913643.
ELECTROMEDICS TISSUE TRAP/ #TT280
K925412 · Electromedics, Inc. · Feb 1993
TISSUE/POLYP TRAP SYSTEM
K902883 · Triton Technology, Inc. · Sep 1990
BUSH NECK W/PLUG
K841409 · Warne Surgical Products, Ltd. · Apr 1984
ONE-WAY AIR VALVE
K840253 · Delta Medical Industries · Apr 1984
SPECIMEN TRAP
K834467 · Microvasive · Feb 1984
CRITICAL MEASUREMENT UNIT
K822556 · Bemis Health Care · Oct 1982
K913643 · MUCOUS SPECIMEN TRAP
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