Cleared Traditional

K850196 - COPAL DIGITAL THERMOMETER UF-22B

K850196 is the FDA 510(k) clearance for COPAL DIGITAL THERMOMETER UF-22B by Takeda Medical, Inc.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K850196 · Takeda Medical, Inc. · General Hospital
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Feb 1985
Decision
20d
Days
Class 2
Risk

K850196 is an FDA 510(k) clearance for the COPAL DIGITAL THERMOMETER UF-22B. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Takeda Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on February 7, 1985 after a review of 20 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - 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 Takeda Medical, Inc. devices

Submission Details

510(k) Number K850196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1985
Decision Date February 07, 1985
Days to Decision 20 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
109d faster than avg
Panel avg: 129d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2910
Definition A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.
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 - FLL Continuous Measurement Thermometer

All 321
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K850196.
THERMOMED
K851704 · Draeger Medical, Inc. · May 1985
CLINICAL ELECTRONIC THERMOMETERS
K850244 · Sheridan Catheter Corp. · Apr 1985
HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTOR
K844201 · Mallinckrodt Critical Care · Mar 1985
TOSHIBA DIGITAL CLINICAL THERMOMETER
K844124 · Toshiba Medical Systems · Dec 1984
TERUMO DIGITAL CLINICAL THERMOMETER
K841740 · Terumo Medical Corp. · Jul 1984
TYCOS SELF-CHECK/DIGITAL FEVER THERMO
K842132 · Sybron Corp. · Jul 1984