Cleared Traditional

K894216 - HAEMOPHILUS TEST MEDIUM (HTM)AGAR

K894216 is an FDA 510(k) clearance for HAEMOPHILUS TEST MEDIUM (HTM)AGAR, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Microbiology device with product code JSO cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K894216 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Dec 1989
Decision
177d
Days
Class 2
Risk

K894216 is an FDA 510(k) clearance for the HAEMOPHILUS TEST MEDIUM (HTM)AGAR. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on December 13, 1989 after a review of 177 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1700 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K894216

510(k) Number K894216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1989
Decision Date December 13, 1989
Days to Decision 177 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
75d slower than avg
Panel avg: 102d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JSO Device Classification - Class 2, Special Controls

Product Code JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

All 37
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K894216.
GC II AGAR WITH ISOVITALEX
K932882 · Becton Dickinson Microbiology Systems · Sep 1993
G C II AGAR WITH SENSIVITALEX
K932879 · Becton Dickinson Microbiology Systems · Sep 1993
HAEMOPHILUS TEST MEDIUM (HTM) BROTH
K903425 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
HAEMOPHILUS TEST MEDIUM (AGAR)
K892928 · Remel Co. · Jun 1989
WILKENS CHALGREN AGAR
K881567 · Acumedia Manufacturers, Inc. · Apr 1988
WILKENS CHALGREN BROTH
K881568 · Acumedia Manufacturers, Inc. · Apr 1988