Cleared Traditional

K813459 - REUSABLE & DISPOSABLE TEMP. PROBES

K813459 is an FDA 510(k) clearance for REUSABLE & DISPOSABLE TEMP. PROBES, manufactured by Electromedics, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K813459 · Electromedics, Inc. · General Hospital
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Mar 1982
Decision
115d
Days
Class 2
Risk

K813459 is an FDA 510(k) clearance for the REUSABLE & DISPOSABLE TEMP. PROBES. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Electromedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 26, 1982 after a review of 115 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 Electromedics, Inc. devices

FDA 510(k) Submission Details - K813459

510(k) Number K813459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1981
Decision Date March 26, 1982
Days to Decision 115 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 129d · This submission: 115d
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 404
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K813459.
HI-LO TEMP SKIN TEMPERATURE SENSOR
K821833 · Mallinckrodt Critical Care · Jul 1982
THERMAL WELL TEMPERATURE SENSOR
K821504 · Mon-A-Therm, Inc. · Jun 1982
DISPOSABLE TEMPERATURE PROBE
K821244 · Shiley, Inc. · May 1982
ELECTRONIC CLINICAL THERMOMETER TEMP PR
K820409 · Y · Mar 1982
CONPHAR DIGITAL THERMOMETER
K813306 · Conphar, Inc. · Jan 1982
SERIES 400 DISPOSABLE TEMPERATURE PROBE
K813639 · Yellow Springs Instrument Co., Inc. · Jan 1982