Cleared Traditional

K921637 - ESP BLOOD CULTURE SYSTEM

K921637 is an FDA 510(k) clearance for ESP BLOOD CULTURE SYSTEM, 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 99-day FDA review.

K921637 · Difco Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
99d
Days
Class 1
Risk

K921637 is an FDA 510(k) clearance for the ESP BLOOD CULTURE SYSTEM. Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by Difco Laboratories, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on July 14, 1992 after a review of 99 days - within the typical 510(k) review window.

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 - K921637

510(k) Number K921637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1992
Decision Date July 14, 1992
Days to Decision 99 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
3d faster than avg
Panel avg: 102d · This submission: 99d
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
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