# K031556: Vivatherm Themperature Measurement System

- Pathway: 510(k) (Traditional)
- Applicant: Vivant Medical, Inc.
- Decided: Jun 23, 2003 after 35 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: 2 generations back to K830592 (1983). 4 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K841105: Multichannel 2000 Fluoroptic Thermomet, Luxtron (1984) Summary page 1.
- K961365: Endocare Electornic Thermometer System, Endocare, Inc. (1996) Summary page 1.
- K843381: Uri TX-100 Multichannel Thermocouple, Uri Therm-X, Inc. (1984) Summary page 1.

## Most influential descendants
- 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
- K181941: Swift System (2018), 3 descendants of its own

## Indications for use
The VivaThermTM Temperature Measurement System is intended to monitor tissue temperatures during clinical procedures requiring temperature feedback.

Source page: https://510kreport.com/device/K031556
Methodology: https://510kreport.com/methodology