Cleared Traditional

K874159 - PATIENT TEMPERATURE MONITOR, MODEL 1000

K874159 is an FDA 510(k) clearance for PATIENT TEMPERATURE MONITOR, manufactured by Sonodyne America, Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K874159 · Sonodyne America, Ltd. · General Hospital
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Nov 1987
Decision
41d
Days
Class 2
Risk

K874159 is an FDA 510(k) clearance for the PATIENT TEMPERATURE MONITOR, MODEL 1000. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Sonodyne America, Ltd. (Morrisville, US). The FDA issued a Cleared decision on November 23, 1987 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 880.2910 - 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 Sonodyne America, Ltd. devices

FDA 510(k) Submission Details - K874159

510(k) Number K874159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date November 23, 1987
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.

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 609
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K874159.
MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR
K874523 · Mon-A-Therm, Inc. · Jan 1988
MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR
K874524 · Mon-A-Therm, Inc. · Jan 1988
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