Cleared Traditional

K972726 - SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM

K972726 is an FDA 510(k) clearance for SNAP SWAB CULTURE COLLECTION AND TRANSP..., manufactured by Medical Packaging Corp.. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K972726 · Medical Packaging Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
79d
Days
Class 1
Risk

K972726 is an FDA 510(k) clearance for the SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Medical Packaging Corp. (Camarillo, US). The FDA issued a Cleared decision on October 8, 1997 after a review of 79 days - a notably fast clearance cycle.

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: 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 Medical Packaging Corp. devices

FDA 510(k) Submission Details - K972726

510(k) Number K972726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1997
Decision Date October 08, 1997
Days to Decision 79 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 102d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

JSM Device Classification - Class 1, General Controls

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 77
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K972726.
TRANSPORT CULTURE MEDIUM DEVICE
K113249 · Puritan Medical Products, LLC · Mar 2012
COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM
K042970 · Copan Diagnostics, Inc. · Dec 2004
CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K
K993812 · Hardy Diagnostics · Dec 1999
CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION)
K970597 · Medical Packaging Corp. · Mar 1997
A.C.T. I
K965149 · Remel Co. · Jan 1997
A.C.T. IV
K965150 · Remel Co. · Jan 1997