Cleared Traditional

K896296 - INPOUCH-TV POUCH

K896296 is an FDA 510(k) clearance for INPOUCH-TV POUCH, manufactured by Biomed Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code JSN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K896296 · Biomed Diagnostics, Inc. · Microbiology device
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Jan 1990
Decision
90d
Days
Class 1
Risk

K896296 is an FDA 510(k) clearance for the INPOUCH-TV POUCH. Classified as Culture Media, Propagating Transport (product code JSN), Class I - General Controls.

Submitted by Biomed Diagnostics, Inc. (San Jose, US). The FDA issued a Cleared decision on January 29, 1990 after a review of 90 days - within the typical 510(k) review window.

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.

View all Biomed Diagnostics, Inc. devices

FDA 510(k) Submission Details - K896296

510(k) Number K896296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1989
Decision Date January 29, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

JSN Device Classification - Class 1, General Controls

Product Code JSN Culture Media, 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 - JSN Culture Media, Propagating Transport

All 8
Devices cleared under the same product code (JSN) and FDA review panel - the closest regulatory comparables to K896296.
ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000)
K962745 · Prepared Media Laboratory, Inc. · Oct 1996
CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM
K961755 · Proteins Intl., Inc. · May 1996
CYTOQUANT VIRAL TRANSPORT MEDIUM
K961756 · Proteins Intl., Inc. · May 1996
AMIES TRANSPORT MEDIUM W/O CHARCOAL
K881579 · Acumedia Manufacturers, Inc. · Apr 1988
10B
K833968 · Remel Co. · Dec 1983
A3B
K834065 · Remel Co. · Dec 1983