Cleared Traditional

K923892 - SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA

K923892 is the FDA 510(k) clearance for SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA by Smith River Biologicals. It is a Class 2 Microbiology device (product code JSO) cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K923892 · Smith River Biologicals · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
321d
Days
Class 2
Risk

K923892 is an FDA 510(k) clearance for the SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Smith River Biologicals (Ferrum, US). The FDA issued a Cleared decision on June 21, 1993 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Smith River Biologicals devices

Submission Details

510(k) Number K923892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1992
Decision Date June 21, 1993
Days to Decision 321 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
219d slower than avg
Panel avg: 102d · This submission: 321d
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 32
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K923892.
BHI AGAR WITH VANCOMYCIN
K941444 · Remel Co. · Sep 1994
GC II AGAR WITH ISOVITALEX
K932882 · Becton Dickinson Microbiology Systems · Sep 1993
G C II AGAR WITH SENSIVITALEX
K932879 · Becton Dickinson Microbiology Systems · Sep 1993
HAEMOPHILUS TEST MEDIUM (HTM) BROTH
K903425 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
HAEMOPHILUS TEST MEDIUM (HTM)AGAR
K894216 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
HAEMOPHILUS TEST MEDIUM (AGAR)
K892928 · Remel Co. · Jun 1989