Cleared Traditional

K972756 - MODIFICATION OF EST CULTURE SYSTEM II - MYCO

K972756 is an FDA 510(k) clearance for MODIFICATION OF EST CULTURE SYSTEM II -..., manufactured by Accumed Intl., Inc.. The device is a Class 1 Microbiology device with product code MDB cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K972756 · Accumed Intl., Inc. · Microbiology device
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Aug 1997
Decision
63d
Days
Class 1
Risk

K972756 is an FDA 510(k) clearance for the MODIFICATION OF EST CULTURE SYSTEM II - MYCO. Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by Accumed Intl., Inc. (Westlake, US). The FDA issued a Cleared decision on August 1, 1997 after a review of 63 days - a notably fast clearance 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: 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 Accumed Intl., Inc. devices

FDA 510(k) Submission Details - K972756

510(k) Number K972756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1997
Decision Date August 01, 1997
Days to Decision 63 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 102d · This submission: 63d
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 57
Devices cleared under the same product code (MDB) and FDA review panel - the closest regulatory comparables to K972756.
BACT/ALERT FAN CULTURE BOTTLES
K973325 · Organon Teknika Corp. · Dec 1997
BACT/ALERT CULTURE BOTTLES
K973305 · Organon Teknika Corp. · Nov 1997
BACTEC MYCO/F-SPUTA CULTURE VIALS
K972758 · Becton Dickinson Microbiology Systems · Aug 1997
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