Cleared Traditional

K925644 - CATION ADJUSTED MUELLER HINTON BROTH

K925644 is the FDA 510(k) clearance for CATION ADJUSTED MUELLER HINTON BROTH by Pasco Laboratories, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K925644 · Pasco Laboratories, Inc. · Microbiology device
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Jan 1993
Decision
67d
Days
Class 2
Risk

K925644 is an FDA 510(k) clearance for the CATION ADJUSTED MUELLER HINTON BROTH. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Pasco Laboratories, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on January 15, 1993 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Pasco Laboratories, Inc. devices

Submission Details

510(k) Number K925644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1992
Decision Date January 15, 1993
Days to Decision 67 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
35d faster than avg
Panel avg: 102d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
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 - JWY Manual Antimicrobial Susceptibility Test Systems

All 360
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K925644.
PASCO MIC AND MIC/ID PANELS
K931069 · Pasco Laboratories, Inc. · May 1993
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K926545 · Baxter Diagnostics, Inc. · Mar 1993
SENSITITRE SUSCEPTIBILITY PLATES
K923045 · Radiometer America, Inc. · Mar 1993
DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS
K922458 · Baxter Healthcare Corp · Dec 1992
API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC
K923684 · Analytical Products, Inc. · Dec 1992
API UNISCEPT KB/TYPE 2 AND 3
K922926 · Analytical Products, Inc. · Oct 1992