Cleared Traditional

K813459 - REUSABLE & DISPOSABLE TEMP. PROBES

K813459 is the FDA 510(k) clearance for REUSABLE & DISPOSABLE TEMP. PROBES by Electromedics, Inc.. It is a Class 2 General Hospital device (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

Submission Details

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
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.

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 244
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K813459.
RECTAL TEMP. TELEMETRY MONITOR
K832404 · Xomed, Inc. · Sep 1983
HI-LO TEMP SKIN TEMPERATURE SENSOR
K821833 · Mallinckrodt Critical Care · Jul 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
TEMPERATURE FUNCTION BLOCK
K810173 · Honeywell, Inc. · Feb 1981