Cleared Traditional

K972758 - BACTEC MYCO/F-SPUTA CULTURE VIALS

K972758 is the FDA 510(k) clearance for BACTEC MYCO/F-SPUTA CULTURE VIALS by Becton Dickinson Microbiology Systems. It is a Class 1 Microbiology device (product code MDB) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K972758 · Becton Dickinson Microbiology Systems · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
53d
Days
Class 1
Risk

K972758 is an FDA 510(k) clearance for the BACTEC MYCO/F-SPUTA CULTURE VIALS. Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by Becton Dickinson Microbiology Systems (Sparks, US). The FDA issued a Cleared decision on August 8, 1997 after a review of 53 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 Becton Dickinson Microbiology Systems devices

Submission Details

510(k) Number K972758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1997
Decision Date August 08, 1997
Days to Decision 53 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
49d faster than avg
Panel avg: 102d · This submission: 53d
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.

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 K972758.
BACTEC MYCO/F LYTIC CULTURE VIALS
K970512 · Becton Dickinson Microbiology Systems · Jan 1998
BACT/ALERT FAN CULTURE BOTTLES
K973325 · Organon Teknika Corp. · Dec 1997
BACT/ALERT CULTURE BOTTLES
K973305 · Organon Teknika Corp. · Nov 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