Cleared Traditional

K951754 - CULTURE MEDIA

K951754 is the FDA 510(k) clearance for CULTURE MEDIA by Hardy Diagnostics. It is a Class 2 Microbiology device (product code JSO) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K951754 · Hardy Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
182d
Days
Class 2
Risk

K951754 is an FDA 510(k) clearance for the CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on October 16, 1995 after a review of 182 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1700 - 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 K951754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1995
Decision Date October 16, 1995
Days to Decision 182 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
80d slower than avg
Panel avg: 102d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

All 28
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K951754.
MRSASELECT
K070361 · Bio-Rad · Sep 2007
BBLCHROMAGAR MRSA
K042812 · Becton, Dickinson & CO · Nov 2004
BHI W/VANCOMYCIN AGAR
K964560 · Hardy Diagnostics · Jan 1997
SYNERGY QUAD
K941443 · Remel Co. · Sep 1994
BHI AGAR WITH VANCOMYCIN
K941444 · Remel Co. · Sep 1994
HAEMOPHILUS TEST MEDIUM (HTM) BROTH
K903425 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990