Cleared Traditional

K882580 - MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE

K882580 is an FDA 510(k) clearance for MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE, manufactured by Precision Dynamics Corp.. The device is a Class 1 Microbiology device with product code JTW cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K882580 · Precision Dynamics Corp. · Microbiology device
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Jul 1988
Decision
17d
Days
Class 1
Risk

K882580 is an FDA 510(k) clearance for the MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE. Classified as System, Transport, Aerobic (product code JTW), Class I - General Controls.

Submitted by Precision Dynamics Corp. (Van Nuys, US). The FDA issued a Cleared decision on July 8, 1988 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - the FDA microbiology 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 - K882580

510(k) Number K882580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1988
Decision Date July 08, 1988
Days to Decision 17 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 102d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

JTW Device Classification - Class 1, General Controls

Product Code JTW System, Transport, Aerobic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - JTW System, Transport, Aerobic

All 42
Devices cleared under the same product code (JTW) and FDA review panel - the closest regulatory comparables to K882580.
CULTURESWAB TRANSPORT SYSTEM
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P AND T MEDIUM
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FDL, INC.'S TRANSPORT SYSTEM
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GONOSTAT FEMALE SPECIMEN COLLECTION & TRANSPORT
K872325 · Technology Management & Marketing, Inc. · Aug 1987
GONOSTAT MALE SPECIMEN COLLECTION & TRANSPORT
K872326 · Technology Management & Marketing, Inc. · Aug 1987
GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK
K843341 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1984
K882580 · MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE
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