Cleared Traditional

K760928 - BLOOD BANK DRI-BATH (FDA 510(k) Clearance)

Class I Microbiology device.

K760928 · Thermolyne Corp. · Microbiology device
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Jan 1977
Decision
73d
Days
Class 1
Risk

K760928 is an FDA 510(k) clearance for the BLOOD BANK DRI-BATH. Classified as Bath, Incubators/water, All (product code JTQ), Class I - General Controls.

Submitted by Thermolyne Corp. (Mchenry, US). The FDA issued a Cleared decision on January 10, 1977 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2540 - 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 Thermolyne Corp. devices

Submission Details

510(k) Number K760928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1976
Decision Date January 10, 1977
Days to Decision 73 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 102d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTQ Bath, Incubators/water, All
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2540
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.