Cleared Traditional

K935711 - BACT/ALERT FAN AEROBIC CULTURE BOTTLE (FDA 510(k) Clearance)

Class I Microbiology device.

K935711 · Organon Teknika Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
273d
Days
Class 1
Risk

K935711 is an FDA 510(k) clearance for the BACT/ALERT FAN AEROBIC CULTURE BOTTLE. Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on August 30, 1994 after a review of 273 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2560 - 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 K935711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1993
Decision Date August 30, 1994
Days to Decision 273 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
171d slower than avg
Panel avg: 102d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MDB System, Blood Culturing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2560
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.