Cleared Traditional

K940686 - ELECTRONIC THERMOMETERS

K940686 is an FDA 510(k) clearance for ELECTRONIC THERMOMETERS, manufactured by American Diagnostic Corp.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K940686 · American Diagnostic Corp. · General Hospital
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Jul 1994
Decision
142d
Days
Class 2
Risk

K940686 is an FDA 510(k) clearance for the ELECTRONIC THERMOMETERS. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by American Diagnostic Corp. (West Babylon, US). The FDA issued a Cleared decision on July 8, 1994 after a review of 142 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 American Diagnostic Corp. devices

FDA 510(k) Submission Details - K940686

510(k) Number K940686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1994
Decision Date July 08, 1994
Days to Decision 142 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 129d · This submission: 142d
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 K940686.
R&D BATTERIES PART NOS. 5164, 5252, 5634 AND 5650
K951403 · R & D Batteries, Inc. · Aug 1995
R&D BATTERIES PART NOS. 5096, 5115, 5128 AND 5131
K951404 · R & D Batteries, Inc. · Aug 1995
B-D DIGITAL THERMOMETER
K935267 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1994
VITAL SIGNS DUAL DISPLAY TEMPERATURE MONITOR, MODEL 1600
K934482 · Vital Signs, Inc. · May 1994
EXAC-TEMP & CLINI-TEMP TYMPANIC & MYOCARDIAL PROBE
K925792 · Deroyal Industries, Inc. · Apr 1994
ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR
K934964 · Electromedics, Inc. · Mar 1994