Cleared Traditional

K881115 - BACTEC NR26 AND BACTEC NR 27 CULTURE MEDIA

K881115 is the FDA 510(k) clearance for BACTEC NR26 AND BACTEC NR 27 CULTURE MEDIA by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K881115 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Mar 1988
Decision
9d
Days
Class 1
Risk

K881115 is an FDA 510(k) clearance for the BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on March 24, 1988 after a review of 9 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K881115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1988
Decision Date March 24, 1988
Days to Decision 9 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
93d faster than avg
Panel avg: 102d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 183
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K881115.
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NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE
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TSA W/LEC. & TWEEN. 80
K880142 · Hardy Media · Mar 1988
NUTRIENT BROTH
K880114 · Hardy Media · Mar 1988
COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750
K875136 · Lakewood Biochemical Co., Inc. · Jan 1988
TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516
K874538 · Lakewood Biochemical Co., Inc. · Nov 1987