Cleared Traditional

K791953 - PDC 304 DOUBLE SWAB CULTURE COLLECTION

K791953 is an FDA 510(k) clearance for PDC 304 DOUBLE SWAB CULTURE COLLECTION, 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 29-day FDA review.

K791953 · Precision Dynamics Corp. · Microbiology device
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Oct 1979
Decision
29d
Days
Class 1
Risk

K791953 is an FDA 510(k) clearance for the PDC 304 DOUBLE SWAB CULTURE COLLECTION. Classified as System, Transport, Aerobic (product code JTW), Class I - General Controls.

Submitted by Precision Dynamics Corp. (Mchenry, US). The FDA issued a Cleared decision on October 30, 1979 after a review of 29 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.

View all Precision Dynamics Corp. devices

FDA 510(k) Submission Details - K791953

510(k) Number K791953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1979
Decision Date October 30, 1979
Days to Decision 29 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
73d faster than avg
Panel avg: 102d · This submission: 29d
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 28
Devices cleared under the same product code (JTW) and FDA review panel - the closest regulatory comparables to K791953.
PRESERV BUFFERED GLYCEROL SALINE
K840991 · Preventive Diagnostics Corp. · Mar 1984
MINI-TIP CULTURETTE
K803298 · Marion Laboratories, Inc. · Jan 1981
CULSWAB CAT.#978 & 979
K802023 · Pollak (Intl.), Ltd. · Sep 1980
PDC 104 SINGLE SWAB CULTURE COLLECTION
K791924 · Precision Dynamics Corp. · Oct 1979
URINE CULTURE KIT
K790366 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1979
CHAMBER, AEROBIC
K780440 · Marion Laboratories, Inc. · Apr 1978