Cleared Traditional

K802023 - CULSWAB CAT.#978 & 979

K802023 is the FDA 510(k) clearance for CULSWAB CAT.#978 & 979 by Pollak (Intl.), Ltd.. It is a Class 1 Microbiology device (product code JTW) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K802023 · Pollak (Intl.), Ltd. · Microbiology device
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Sep 1980
Decision
20d
Days
Class 1
Risk

K802023 is an FDA 510(k) clearance for the CULSWAB CAT.#978 & 979. Classified as System, Transport, Aerobic (product code JTW), Class I - General Controls.

Submitted by Pollak (Intl.), Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1980 after a review of 20 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 Pollak (Intl.), Ltd. devices

Submission Details

510(k) Number K802023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1980
Decision Date September 09, 1980
Days to Decision 20 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
82d faster than avg
Panel avg: 102d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 14
Devices cleared under the same product code (JTW) and FDA review panel - the closest regulatory comparables to K802023.
GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK
K843341 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1984
CELL-MATICS VIRAL TRANSPORT PACK
K843173 · Difco Laboratories, Inc. · Sep 1984
MINI-TIP CULTURETTE
K803298 · Marion Laboratories, Inc. · Jan 1981
URINE CULTURE KIT
K790366 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1979
CHAMBER, AEROBIC
K780440 · Marion Laboratories, Inc. · Apr 1978
EPTONE BACK-UP BROTH, VACUTAINER
K771058 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1977