Cleared Traditional

K873261 - ENTERIC ISOLATION MEDIA

K873261 is an FDA 510(k) clearance for ENTERIC ISOLATION MEDIA, manufactured by Central Media. The device is a Class 1 Microbiology device with product code JSI cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K873261 · Central Media · Microbiology device
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Oct 1987
Decision
78d
Days
Class 1
Risk

K873261 is an FDA 510(k) clearance for the ENTERIC ISOLATION MEDIA. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Central Media (Sacramento, US). The FDA issued a Cleared decision on October 28, 1987 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 Central Media devices

FDA 510(k) Submission Details - K873261

510(k) Number K873261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1987
Decision Date October 28, 1987
Days to Decision 78 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 102d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

JSI Device Classification - Class 1, General Controls

Product Code JSI Culture Media, Selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSI Culture Media, Selective And Differential

All 214
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K873261.
ATS MEDIA
K880130 · Hardy Media · Mar 1988
DERMATOPHYTE TEST MEDIUM
K880132 · Hardy Media · Mar 1988
QUAD PLATE (4 DIFFERENT MEDIA)
K874344 · Lakewood Biochemical Co., Inc. · Nov 1987
HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016
K873481 · Lakewood Biochemical Co., Inc. · Oct 1987
HEKTOEN ENTERIC (HE) AGAR PRODUCT #P3330
K873329 · Lakewood Biochemical Co., Inc. · Oct 1987
MACCONKEY AGAR - PRODUCT #P1606
K873223 · Lakewood Biochemical Co., Inc. · Sep 1987