Cleared Traditional

K871640 - ALKALINE PEPTONE WATER

K871640 is an FDA 510(k) clearance for ALKALINE PEPTONE WATER, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Microbiology device with product code JSD cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K871640 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1987
Decision
16d
Days
Class 1
Risk

K871640 is an FDA 510(k) clearance for the ALKALINE PEPTONE WATER. Classified as Culture Media, Selective Broth (product code JSD), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 13, 1987 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 - K871640

510(k) Number K871640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1987
Decision Date May 13, 1987
Days to Decision 16 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
86d faster than avg
Panel avg: 102d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

JSD Device Classification - Class 1, General Controls

Product Code JSD Culture Media, Selective Broth
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSD Culture Media, Selective Broth

All 20
Devices cleared under the same product code (JSD) and FDA review panel - the closest regulatory comparables to K871640.
SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331
K873324 · Lakewood Biochemical Co., Inc. · Oct 1987
BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802
K873218 · Lakewood Biochemical Co., Inc. · Sep 1987
TODD HEWITT W/CNA (LIM BROTH)
K871447 · Remel Co. · May 1987
T9802 TSB W/6.5% NACL
K870594 · Lakewood Biochemical Co., Inc. · Mar 1987
TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE
K844547 · bioMerieux, Inc. · Jan 1985
SF BROTH
K834013 · Micro Media Laboratories · Dec 1983