Cleared Traditional

K961365 - ENDOCARE ELECTORNIC THERMOMETER SYSTEM

K961365 is an FDA 510(k) clearance for ENDOCARE ELECTORNIC THERMOMETER SYSTEM, manufactured by Endocare, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K961365 · Endocare, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
128d
Days
Class 2
Risk

K961365 is an FDA 510(k) clearance for the ENDOCARE ELECTORNIC THERMOMETER SYSTEM. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Endocare, Inc. (Irvine, US). The FDA issued a Cleared decision on August 15, 1996 after a review of 128 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 Endocare, Inc. devices

FDA 510(k) Submission Details - K961365

510(k) Number K961365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1996
Decision Date August 15, 1996
Days to Decision 128 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 129d · This submission: 128d
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 583
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K961365.
TALKING DIGITAL THERMOMETER
K962369 · Ultmost Industrial Corp. · Aug 1996
SENSOR SHEATH TS1
K962386 · Radiotherapeutics Corp. · Aug 1996
PRO-FLEX, DIGITAL THERMOMETER WITH FLEXIBLE PROBE
K961357 · Intelligent Product Limited Co. · Aug 1996
YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE
K962070 · Yellow Springs Instrument Co., Inc. · Jul 1996
LUMISCOPE MODEL 2018 THERMOMETER
K954792 · Lumiscope Co., Inc. · Jun 1996
ELECTRONIC THERMOMETER
K961879 · Wiltec Industries , Ltd. · Jun 1996