Cleared Traditional

K870641 - TRYPTONE BROTH, 2%

K870641 is an FDA 510(k) clearance for TRYPTONE BROTH, manufactured by Hardy Media. The device is a Class 1 Microbiology device with product code JSF cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K870641 · Hardy Media · Microbiology device
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Apr 1987
Decision
60d
Days
Class 1
Risk

K870641 is an FDA 510(k) clearance for the TRYPTONE BROTH, 2%. Classified as Culture Media, Single Biochemical Test (product code JSF), Class I - General Controls.

Submitted by Hardy Media (Santa Barbara, US). The FDA issued a Cleared decision on April 14, 1987 after a review of 60 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

FDA 510(k) Submission Details - K870641

510(k) Number K870641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1987
Decision Date April 14, 1987
Days to Decision 60 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
42d faster than avg
Panel avg: 102d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

JSF Device Classification - Class 1, General Controls

Product Code JSF Culture Media, Single 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 - JSF Culture Media, Single Biochemical Test

All 62
Devices cleared under the same product code (JSF) and FDA review panel - the closest regulatory comparables to K870641.
NUTRIENT GELATIN
K880115 · Hardy Media · Mar 1988
CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990
K873828 · Lakewood Biochemical Co., Inc. · Oct 1987
IAFP UREA AGAR SLANT
K872691 · I.A.F. Production, Inc. · Aug 1987
DNASE AGAR
K864241 · Mds Laboratories, Inc. · Mar 1987
TRYPTONE WATER (1%)
K864256 · Mds Laboratories, Inc. · Mar 1987
BIOTIS MOTILITY TEST MEDIUM
K862392 · Otisville Biotech, Inc. · Jul 1986