Cleared Traditional

K803298 - MINI-TIP CULTURETTE

K803298 is an FDA 510(k) clearance for MINI-TIP CULTURETTE, manufactured by Marion Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JTW cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K803298 · Marion Laboratories, Inc. · Microbiology device
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Jan 1981
Decision
13d
Days
Class 1
Risk

K803298 is an FDA 510(k) clearance for the MINI-TIP CULTURETTE. Classified as System, Transport, Aerobic (product code JTW), Class I - General Controls.

Submitted by Marion Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on January 12, 1981 after a review of 13 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 Marion Laboratories, Inc. devices

FDA 510(k) Submission Details - K803298

510(k) Number K803298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1980
Decision Date January 12, 1981
Days to Decision 13 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
89d faster than avg
Panel avg: 102d · This submission: 13d
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 K803298.
PRESERV TRANSPORT & CULTURE PACK
K840968 · Preventive Diagnostics Corp. · Mar 1984
PRESERV CARY BLAIR TRANSPORT PACK
K840990 · Preventive Diagnostics Corp. · Mar 1984
PRESERV BUFFERED GLYCEROL SALINE
K840991 · Preventive Diagnostics Corp. · Mar 1984
CULSWAB CAT.#978 & 979
K802023 · Pollak (Intl.), Ltd. · Sep 1980
PDC 304 DOUBLE SWAB CULTURE COLLECTION
K791953 · Precision Dynamics Corp. · Oct 1979
PDC 104 SINGLE SWAB CULTURE COLLECTION
K791924 · Precision Dynamics Corp. · Oct 1979