Cleared Traditional

K844624 - BASIS DIGITAL THERMOMETER MODEL BTM-1

K844624 is an FDA 510(k) clearance for BASIS DIGITAL THERMOMETER MODEL BTM-1, manufactured by Terayco Intl., Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K844624 · Terayco Intl., Ltd. · General Hospital
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Mar 1985
Decision
114d
Days
Class 2
Risk

K844624 is an FDA 510(k) clearance for the BASIS DIGITAL THERMOMETER MODEL BTM-1. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Terayco Intl., Ltd. (Littleton, US). The FDA issued a Cleared decision on March 21, 1985 after a review of 114 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Terayco Intl., Ltd. devices

FDA 510(k) Submission Details - K844624

510(k) Number K844624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1984
Decision Date March 21, 1985
Days to Decision 114 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
15d faster than avg
Panel avg: 129d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

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 561
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K844624.
YSI MODEL 791/799 DISP TEMP PROBE & 7900 EX CABLE
K852246 · Yellow Springs Instrument Co., Inc. · Jun 1985
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