Cleared Traditional

K870639 - BHI WITH SHEEP BLOOD (5%)

K870639 is an FDA 510(k) clearance for BHI WITH SHEEP BLOOD (5%), manufactured by Hardy Media. The device is a Class 1 Microbiology device with product code JSG cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K870639 · Hardy Media · Microbiology device
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Apr 1987
Decision
60d
Days
Class 1
Risk

K870639 is an FDA 510(k) clearance for the BHI WITH SHEEP BLOOD (5%). Classified as Culture Media, Non-selective And Non-differential (product code JSG), 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 866.2300 - 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 - K870639

510(k) Number K870639 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.

JSG Device Classification - Class 1, General Controls

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 189
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K870639.
IAFP T.S.A. W/10% SHEEP BLOOD
K872668 · I.A.F. Production, Inc. · Aug 1987
IAFP B.H.I. AGAR
K872677 · I.A.F. Production, Inc. · Aug 1987
IAFP T.S.A. (TRYPTIC SOY AGAR)
K872679 · I.A.F. Production, Inc. · Aug 1987
ANAEROBIC BLOOD AGAR (CDC FORMULATION)
K871089 · bioMerieux, Inc. · Apr 1987
TRYPTIC SOY AGAR
K871098 · bioMerieux, Inc. · Apr 1987
COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD
K864240 · Mds Laboratories, Inc. · Mar 1987