Cleared Traditional

K935987 - FLEXTRANS

K935987 is an FDA 510(k) clearance for FLEXTRANS, manufactured by Baxter Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K935987 · Baxter Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
244d
Days
Class 1
Risk

K935987 is an FDA 510(k) clearance for the FLEXTRANS. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Baxter Diagnostics, Inc. (Issaquash, US). The FDA issued a Cleared decision on August 15, 1994 after a review of 244 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K935987

510(k) Number K935987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1993
Decision Date August 15, 1994
Days to Decision 244 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
142d slower than avg
Panel avg: 102d · This submission: 244d
Pathway characteristics
Predicate-based equivalence.

JSM Device Classification - Class 1, General Controls

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 K935987.
MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5)
K941579 · Microtest · Oct 1994
CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM
K932337 · Medical Packaging Corp. · Aug 1994
CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED
K936078 · Medical Packaging Corp. · Aug 1994
SPECIMEN TRANSPORT MEDIUM
K935618 · Biowhittaker Molecular Applications, Inc. · Apr 1994
DIADOT(TM) VIRUS/CHLAMYDIA TRANSPORT
K931922 · Viratest Intl., Inc. · Mar 1994
M4-RT TRANSPORT MEDIUM, (M4 MODIFICATION)
K921472 · Microtest · May 1992
K935987 · FLEXTRANS
Download PDF FDA Summary Baxter Diagnostics, I…