Cleared Traditional

K792060 - TEMPTRONIC 100 WATER BATH (FDA 510(k) Clearance)

Class I Immunology device.

K792060 · Sybron Corp. · Immunology device
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Dec 1979
Decision
50d
Days
Class 1
Risk

K792060 is an FDA 510(k) clearance for the TEMPTRONIC 100 WATER BATH. Classified as Bath, Incubators/water, All (product code JTQ), Class I - General Controls.

Submitted by Sybron Corp. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1979 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.2540 - the FDA immunology 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 Sybron Corp. devices

Submission Details

510(k) Number K792060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1979
Decision Date December 04, 1979
Days to Decision 50 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 104d · This submission: 50d
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.