Cleared Traditional

K880116 - MRVP BROTH

K880116 is the FDA 510(k) clearance for MRVP BROTH by Hardy Media. It is a Class 1 Microbiology device (product code JSE) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K880116 · Hardy Media · Microbiology device
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Mar 1988
Decision
85d
Days
Class 1
Risk

K880116 is an FDA 510(k) clearance for the MRVP BROTH. Classified as Culture Media, Multiple Biochemical Test (product code JSE), Class I - General Controls.

Submitted by Hardy Media (Santa Barbara, US). The FDA issued a Cleared decision on March 31, 1988 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - 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 Hardy Media devices

Submission Details

510(k) Number K880116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1988
Decision Date March 31, 1988
Days to Decision 85 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
17d faster than avg
Panel avg: 102d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSE Culture Media, Multiple Biochemical Test
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSE Culture Media, Multiple Biochemical Test

All 38
Devices cleared under the same product code (JSE) and FDA review panel - the closest regulatory comparables to K880116.
MLX MICROTITER PLATE LUMINOMETER
K962265 · Dynatech Laboratories, Inc. · Jul 1996
MIL MEDIUM
K880133 · Hardy Media · Mar 1988
KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR
K874537 · Lakewood Biochemical Co., Inc. · Nov 1987
CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES
K871096 · bioMerieux, Inc. · Apr 1987
BIOTIS LITMUS MILK
K862393 · Otisville Biotech, Inc. · Jul 1986
BIOTIS SIM MEDIUM
K860412 · Otisville Biotech, Inc. · Feb 1986