Cleared Traditional

K771847 - TEMP-TESTER

K771847 is an FDA 510(k) clearance for TEMP-TESTER, manufactured by Jablecki, Charles, Dr.. The device is a Class 1 Chemistry device with product code GXB cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K771847 · Jablecki, Charles, Dr. · Chemistry device
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Nov 1977
Decision
35d
Days
Class 1
Risk

K771847 is an FDA 510(k) clearance for the TEMP-TESTER. Classified as Esthesiometer (product code GXB), Class I - General Controls.

Submitted by Jablecki, Charles, Dr. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1977 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 882.1500 - the FDA in vitro diagnostics and chemistry 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 Jablecki, Charles, Dr. devices

FDA 510(k) Submission Details - K771847

510(k) Number K771847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1977
Decision Date November 02, 1977
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

GXB Device Classification - Class 1, General Controls

Product Code GXB Esthesiometer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1500
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.