Cleared Traditional

K802023 - CULSWAB CAT.#978 & 979

K802023 is an FDA 510(k) clearance for CULSWAB CAT.#978 & 979, manufactured by Pollak (Intl.), Ltd.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K802023

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.

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 29
Devices cleared under the same product code (JTW) and FDA review panel - the closest regulatory comparables to K802023.
PRESERV CARY BLAIR TRANSPORT PACK
K840990 · Preventive Diagnostics Corp. · Mar 1984
PRESERV BUFFERED GLYCEROL SALINE
K840991 · Preventive Diagnostics Corp. · Mar 1984
MINI-TIP CULTURETTE
K803298 · Marion Laboratories, Inc. · Jan 1981
PDC 304 DOUBLE SWAB CULTURE COLLECTION
K791953 · Precision Dynamics Corp. · Oct 1979
PDC 104 SINGLE SWAB CULTURE COLLECTION
K791924 · Precision Dynamics Corp. · Oct 1979
URINE CULTURE KIT
K790366 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1979