# K961365: Endocare Electornic Thermometer System

- Pathway: 510(k) (Traditional)
- Applicant: Endocare, Inc.
- Decided: Aug 15, 1996 after 128 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K830592 (1983). 1 ancestor in all.
21 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830592: Dispos. Type T Thermocouple Temp.Probe, Electromedics, Inc. (1983) Summary page 1.
- (no number) Bailey BAT-8 clinical monitoring thermometers: named in the summary without a submission number

## Most influential descendants
- K031556: Vivatherm Themperature Measurement System (2003), 20 descendants of its own
- K052919: Microsulis Tissue Ablation System (2006), 15 descendants of its own
- K072870: Microwave Tissue Coagulation System (MTCS) (2008), 11 descendants of its own
- K082819: Dermatologic Treatment System (DTS) G2 (2009), 10 descendants of its own
- K103014: Miradry System (2011), 5 descendants of its own

## Indications for use
The Endocare Electronic Thermometer System are designed for use in General Surgery, Urology, and Gynecology to monitor tissue temperatures during thermotherapy, cryosurgery, or normal intra operative feedback.

Source page: https://510kreport.com/device/K961365
Methodology: https://510kreport.com/methodology