Cleared Traditional

K811631 - THERMOMETER (MADE IN CHINA)

K811631 is the FDA 510(k) clearance for THERMOMETER (MADE IN CHINA) by Robert I. Chien & Assoc., Inc.. It is a Class 2 General Hospital device (product code FLK) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K811631 · Robert I. Chien & Assoc., Inc. · General Hospital
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Jul 1981
Decision
41d
Days
Class 2
Risk

K811631 is an FDA 510(k) clearance for the THERMOMETER (MADE IN CHINA). Classified as Thermometer, Clinical Mercury (product code FLK), Class II - Special Controls.

Submitted by Robert I. Chien & Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1981 after a review of 41 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2920 - the FDA general hospital 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 Robert I. Chien & Assoc., Inc. devices

Submission Details

510(k) Number K811631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1981
Decision Date July 20, 1981
Days to Decision 41 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 129d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLK Thermometer, Clinical Mercury
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLK Thermometer, Clinical Mercury

All 8
Devices cleared under the same product code (FLK) and FDA review panel - the closest regulatory comparables to K811631.
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TEMPO2-II DISPOSABLE THERMOMETERS
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