Cleared Traditional

K955451 - CVM TRANSPORT

K955451 is the FDA 510(k) clearance for CVM TRANSPORT by Hardy Diagnostics. It is a Class 1 Microbiology device (product code JSM) cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K955451 · Hardy Diagnostics · Microbiology device
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Jul 1996
Decision
236d
Days
Class 1
Risk

K955451 is an FDA 510(k) clearance for the CVM TRANSPORT. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on July 22, 1996 after a review of 236 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Hardy Diagnostics devices

Submission Details

510(k) Number K955451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1995
Decision Date July 22, 1996
Days to Decision 236 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 102d · This submission: 236d
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 48
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K955451.
A.C.T. IV
K965150 · Remel Co. · Jan 1997
A.C.T. III
K965151 · Remel Co. · Jan 1997
A.C.T. II
K965152 · Remel Co. · Jan 1997
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