Cleared Traditional

K953129 - ESP CULTURE SYSTEM - MYCO

K953129 is an FDA 510(k) clearance for ESP CULTURE SYSTEM - MYCO, manufactured by Difco Laboratories, Inc.. The device is a Class 1 Microbiology device with product code MDB cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K953129 · Difco Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
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Dec 1995
Decision
173d
Days
Class 1
Risk

K953129 is an FDA 510(k) clearance for the ESP CULTURE SYSTEM - MYCO. Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by Difco Laboratories, Inc. (Livouia, US). The FDA issued a Cleared decision on December 26, 1995 after a review of 173 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 Difco Laboratories, Inc. devices

FDA 510(k) Submission Details - K953129

510(k) Number K953129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1995
Decision Date December 26, 1995
Days to Decision 173 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
71d slower than avg
Panel avg: 102d · This submission: 173d
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 67
Devices cleared under the same product code (MDB) and FDA review panel - the closest regulatory comparables to K953129.
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