Cleared Traditional

K163436 - Greiner Vacuette Urine Count and Culture, Mannitol tube (FDA 510(k) Clearance)

Class I Microbiology device.

K163436 · Greiner Bio-One Na, Inc. · Microbiology device
Mar 2017
Decision
89d
Days
Class 1
Risk

K163436 is an FDA 510(k) clearance for the Greiner Vacuette Urine Count and Culture, Mannitol tube. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Greiner Bio-One Na, Inc. (Monroe, US). The FDA issued a Cleared decision on March 6, 2017 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K163436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2016
Decision Date March 06, 2017
Days to Decision 89 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 174d · This submission: 89d
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

Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K163436.
Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device
K242976 · Medical Wire & Equipment Company (Bath), Ltd. · Nov 2025
Babio® Virus Transport Kit (Non-inactivating)
K250205 · Jinan Babio Biotechnology Co., Ltd. · Sep 2025
Viral Transport Medium
K233534 · Hardy Diagnostics · Aug 2024
Cultura Collection and Transport System
K201674 · Merit Medical Systems, Inc. · Mar 2021