Cleared Traditional

K936078 - CULTURE-PAK COLLECTION/TRANSPORT SYSTEM

K936078 is the FDA 510(k) clearance for CULTURE-PAK COLLECTION/TRANSPORT SYSTEM by Medical Packaging Corp.. It is a Class 1 Microbiology device (product code JSM) cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K936078 · Medical Packaging Corp. · Microbiology device
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Aug 1994
Decision
326d
Days
Class 1
Risk

K936078 is an FDA 510(k) clearance for the CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Medical Packaging Corp. (Bethesda, US). The FDA issued a Cleared decision on August 16, 1994 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Packaging Corp. devices

Submission Details

510(k) Number K936078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1993
Decision Date August 16, 1994
Days to Decision 326 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
224d slower than avg
Panel avg: 102d · This submission: 326d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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 - JSM Culture Media, Non-propagating Transport

All 53
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K936078.
A.C.T. III
K965151 · Remel Co. · Jan 1997
A.C.T. II
K965152 · Remel Co. · Jan 1997
CVM TRANSPORT
K955451 · Hardy Diagnostics · Jul 1996
FLEXTRANS
K935987 · Baxter Diagnostics, Inc. · Aug 1994
AEROBIC FOAM SWAB CULTURETTE(R)
K913789 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
BACTI-SWAB
K910180 · Remel Co. · May 1991