Cleared Traditional

K873266 - MIDDLEBROOK BASED MEDIA

K873266 is an FDA 510(k) clearance for MIDDLEBROOK BASED MEDIA, manufactured by Central Media. The device is a Class 1 Microbiology device with product code KZI cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K873266 · Central Media · Microbiology device
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Oct 1987
Decision
78d
Days
Class 1
Risk

K873266 is an FDA 510(k) clearance for the MIDDLEBROOK BASED MEDIA. Classified as Culture Media, Enriched (product code KZI), 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 866.2330 - 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.

FDA 510(k) Submission Details - K873266

510(k) Number K873266 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 102d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

KZI Device Classification - Class 1, General Controls

Product Code KZI Culture Media, Enriched
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2330
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 - KZI Culture Media, Enriched

All 41
Devices cleared under the same product code (KZI) and FDA review panel - the closest regulatory comparables to K873266.
BIOTIS (TM) SABHI (DOUBLE POUR)
K874179 · Otisville Biopharm, Inc. · Jan 1988
BIOTIS (TM) BCYE
K874177 · Otisville Biopharm, Inc. · Dec 1987
ECG BASED MEDIA
K873267 · Central Media · Nov 1987
MICRO CULTURE MEDIA P3141, P3136, P3148, P3748
K873952 · Lakewood Biochemical Co., Inc. · Oct 1987
SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD
K873320 · Lakewood Biochemical Co., Inc. · Sep 1987
SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300
K873321 · Lakewood Biochemical Co., Inc. · Sep 1987
K873266 · MIDDLEBROOK BASED MEDIA
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