Cleared Traditional

K933939 - BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K933939 · Organon Teknika Corp. · Microbiology device
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Feb 1994
Decision
179d
Days
Class 2
Risk

K933939 is an FDA 510(k) clearance for the BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT. Classified as Tubes, Vacuum Sample, With Anticoagulant (product code GIM), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on February 7, 1994 after a review of 179 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1675 - 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 Organon Teknika Corp. devices

Submission Details

510(k) Number K933939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1993
Decision Date February 07, 1994
Days to Decision 179 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 102d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GIM Tubes, Vacuum Sample, With Anticoagulant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 - GIM Tubes, Vacuum Sample, With Anticoagulant

All 38
Devices cleared under the same product code (GIM) and FDA review panel - the closest regulatory comparables to K933939.
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