Cleared Traditional

AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA (K863164) - FDA 510(k) Clearance

Class I Microbiology device.

K863164 · Precision Dynamics Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1986
Decision
9d
Days
Class 1
Risk

K863164 is an FDA 510(k) clearance for the AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Precision Dynamics Corp. (San Fernando, US). The FDA issued a Cleared decision on August 27, 1986 after a review of 9 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.

View all Precision Dynamics Corp. devices

Submission Details

510(k) Number K863164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1986
Decision Date August 27, 1986
Days to Decision 9 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 102d · This submission: 9d
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

All 110
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K863164.
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
AllTest Viral Transport Medium
K242576 · Hangzhou AllTest Biotech Co., Ltd. · Apr 2025
UriSponge™
K232565 · Copan Italia Spa · Oct 2024
Ensol EnTM Specimen Collection and Transport System
K220908 · Ensol Biosciences, Inc. · Aug 2024
OmniTrans Transport System
K240235 · Shenzhen Dakewe Bio-Engineering Co., Ltd. · Aug 2024