Cleared Traditional

K781390 - MYCOPLASMA HYORHINIS (BTS-7) (FDA 510(k) Clearance)

Class I Pathology device.

K781390 · Flow Laboratories, Inc. · Pathology device
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Sep 1978
Decision
22d
Days
Class 1
Risk

K781390 is an FDA 510(k) clearance for the MYCOPLASMA HYORHINIS (BTS-7). Classified as Media And Components, Mycoplasma Detection (product code KPB), Class I - General Controls.

Submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 1, 1978 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2360 - the FDA pathology 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 Flow Laboratories, Inc. devices

Submission Details

510(k) Number K781390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1978
Decision Date September 01, 1978
Days to Decision 22 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 77d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KPB Media And Components, Mycoplasma Detection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2360
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.