Cleared Traditional

K760588 - IMPROVED THAYER MARTIN MEDIUM

K760588 is the FDA 510(k) clearance for IMPROVED THAYER MARTIN MEDIUM by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Microbiology device (product code JTY) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K760588 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Oct 1976
Decision
34d
Days
Class 2
Risk

K760588 is an FDA 510(k) clearance for the IMPROVED THAYER MARTIN MEDIUM. Classified as Culture Media, For Isolation Of Pathogenic Neisseria (product code JTY), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on October 7, 1976 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2410 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K760588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1976
Decision Date October 07, 1976
Days to Decision 34 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 102d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JTY Culture Media, For Isolation Of Pathogenic Neisseria
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2410
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 - JTY Culture Media, For Isolation Of Pathogenic Neisseria

All 51
Devices cleared under the same product code (JTY) and FDA review panel - the closest regulatory comparables to K760588.
IMPROVED THAYER MARTIN (JEMBEC)
K770875 · Granite Diagnostics, Inc. · Jun 1977
IMPROVED TRANSGROW
K770876 · Granite Diagnostics, Inc. · Jun 1977
MARTIN-LEWIS AGAR MEDIUM
K770287 · Gibco Laboratories Life Technologies, Inc. · Feb 1977
THAYER-MARTIN MEDIUM WITH ANSIOMYCIN
K760690 · Flow Laboratories, Inc. · Oct 1976
THAYER-MARTIN MEDIUM W/TRIMETHOPRIN L
K760691 · Flow Laboratories, Inc. · Oct 1976
MARTIN-LESTER TRANSGROW W/TRIMETHOPRIN
K760692 · Flow Laboratories, Inc. · Oct 1976