Cleared Traditional

K851873 - FORTEC MI-305

K851873 is an FDA 510(k) clearance for FORTEC MI-305, manufactured by Nam Tai , Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K851873 · Nam Tai , Ltd. · General Hospital
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May 1985
Decision
14d
Days
Class 2
Risk

K851873 is an FDA 510(k) clearance for the FORTEC MI-305. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Nam Tai , Ltd. (Kowloon, Hong Kong, HK). The FDA issued a Cleared decision on May 13, 1985 after a review of 14 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 Nam Tai , Ltd. devices

FDA 510(k) Submission Details - K851873

510(k) Number K851873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1985
Decision Date May 13, 1985
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
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 566
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K851873.
TOSHIBA DIGITAL CLINICAL THERMOMTER
K852903 · Toshiba Medical Systems · Jul 1985
CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORS
K852087 · Terumo Medical Corp. · Jun 1985
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