Cleared Traditional

K871701 - ARYLSULFATASE BROTH

K871701 is an FDA 510(k) clearance for ARYLSULFATASE BROTH, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Microbiology device with product code JSH cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K871701 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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May 1987
Decision
19d
Days
Class 1
Risk

K871701 is an FDA 510(k) clearance for the ARYLSULFATASE BROTH. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 20, 1987 after a review of 19 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K871701

510(k) Number K871701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1987
Decision Date May 20, 1987
Days to Decision 19 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
83d faster than avg
Panel avg: 102d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

JSH Device Classification - Class 1, General Controls

Product Code JSH Culture Media, Non-selective And Differential
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 - JSH Culture Media, Non-selective And Differential

All 108
Devices cleared under the same product code (JSH) and FDA review panel - the closest regulatory comparables to K871701.
IAFP MAC CONKEY AGAR
K872670 · I.A.F. Production, Inc. · Aug 1987
MUCATE AGAR, SLANTS AND MUCATE BROTH
K872020 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1987
SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM
K871855 · Gibco Laboratories Life Technologies, Inc. · May 1987
HEMOPHILUS ID QUAD PLATE
K870636 · Hardy Media · Apr 1987
BIGGY AGAR
K870651 · Hardy Media · Apr 1987
CLED AGAR
K871095 · bioMerieux, Inc. · Apr 1987