Cleared Traditional

K935711 - BACT/ALERT FAN AEROBIC CULTURE BOTTLE

K935711 is an FDA 510(k) clearance for BACT/ALERT FAN AEROBIC CULTURE BOTTLE, manufactured by Organon Teknika Corp.. The device is a Class 1 Microbiology device with product code MDB cleared through the Traditional 510(k) pathway after a 273-day FDA review.

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

FDA 510(k) Submission Details - K935711

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 102d · This submission: 273d
Pathway characteristics
Predicate-based equivalence.

MDB Device Classification - Class 1, General Controls

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.

Regulatory Peers - MDB System, Blood Culturing

All 56
Devices cleared under the same product code (MDB) and FDA review panel - the closest regulatory comparables to K935711.
MB/BACT MYCROBACTERIA DETECTION SYSTEM
K954468 · Organon Teknika Corp. · Jul 1996
ESP CULTURE SYSTEM - MYCO
K953129 · Difco Laboratories, Inc. · Dec 1995
BACT/ALERT FAN CULTURE BOTTLE
K944594 · Organon Teknika Corp. · Feb 1995
BACT/ALERT 120
K934593 · Organon Teknika Corp. · Feb 1994
BACTEC PEDS PLUS/F
K926304 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1993
EZ VIEW
K925693 · Difco Laboratories, Inc. · Jan 1993