Cleared Traditional

K872584 - FORTEC MI-306

K872584 is the FDA 510(k) clearance for FORTEC MI-306 by Nam Tai , Ltd.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K872584 · Nam Tai , Ltd. · General Hospital
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Jul 1987
Decision
26d
Days
Class 2
Risk

K872584 is an FDA 510(k) clearance for the FORTEC MI-306, MI-327 DIGITAL THERMOMETER. 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 July 27, 1987 after a review of 26 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

Submission Details

510(k) Number K872584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1987
Decision Date July 27, 1987
Days to Decision 26 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
103d faster than avg
Panel avg: 129d · This submission: 26d
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 320
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K872584.
HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR
K874568 · Mallinckrodt Critical Care · Jan 1988
HI-LO TEMP(R) SKIN TEMPERATURE SENSOR
K874404 · Mallinckrodt Critical Care · Nov 1987
THERMOCOUPLE ADAPTER
K873833 · Mallinckrodt Critical Care · Nov 1987
THERMOMETER SHEATHS
K871465 · Abco Dealers, Inc. · May 1987
DISPOSABLE PHARMASEAL TEMPERATURE MONITORING PROBE
K864397 · American Pharmaseal Div. Ahsc · Dec 1986
IVAC MODEL 2080 ELECTRONIC THERMOMETER
K860436 · Y · Feb 1986