510(k) · Cleared

Cleared

Vivatherm Themperature Measurement System

K031556510(k) TraditionalCleared Jun 23, 200335-day reviewClass II21 CFR 880.2910

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vivant Medical, Inc. · FLL Continuous Measurement Thermometer

Cleared on Jun 23, 2003 as substantially equivalent to K841105 (Luxtron, 1984) and 2 other predicates after a 35-day review. Its family tree reaches back 2 generations to 1983. 20 later devices descend from it.

Decided: Jun 23, 2003
Review: 35 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K830592 (1983). 4 ancestors in all. 20 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK830592 Dispos. Type T Thermocouple Temp.ProbeElectromedics, Inc. · 1983
1 generation backK961365 Endocare Electornic Thermometer SystemEndocare, Inc. · 1996
This deviceK031556 Vivatherm Themperature Measurement SystemVivant Medical, Inc. · 2003
Descendant · cites it directly · 15 of its ownK052919 Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006
Descendant · 2 generations on · 11 of its ownK072870 Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008
Descendant · 3 generations on · 10 of its ownK082819 Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009
Descendant · 4 generations on · 5 of its ownK103014 Miradry SystemMiramar Labs, Inc. · 2011 · Recalled
Descendant · 3 generations on · 3 of its ownK181941 Swift SystemEmblation, Ltd. · 2018

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2006high 4 (2015) · low 0 (2012)2026

Most influential descendants

Showing 5 of 20 · See all

K052919Microsulis Tissue Ablation SystemMicrosulis Americas, Inc. · 2006 · cites it directly15descendants
K072870Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc. · 2008 · 2 generations on11descendants
K082819Dermatologic Treatment System (DTS) G2Miramar Labs, Inc. · 2009 · 3 generations on10descendants
K103014Miradry SystemMiramar Labs, Inc. · 2011 · 4 generations on5descendants
K181941Swift SystemEmblation, Ltd. · 2018 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K830592	Dispos. Type T Thermocouple Temp.Probe	Electromedics, Inc.	1983	—
−1	K961365	Endocare Electornic Thermometer System	Endocare, Inc.	1996	—
0 (this device)	K031556	Vivatherm Themperature Measurement System	Vivant Medical, Inc.	2003	—
+1	K052919	Microsulis Tissue Ablation System	Microsulis Americas, Inc.	2006	—
+2	K072870	Microwave Tissue Coagulation System (MTCS)	Foundry Newco X, Inc.	2008	—
+3	K082819	Dermatologic Treatment System (DTS) G2	Miramar Labs, Inc.	2009	—
+4	K103014	Miradry System	Miramar Labs, Inc.	2011	2
+3	K181941	Swift System	Emblation, Ltd.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1984	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	2	0
2008	2	0
2009	2	0
2010	1	0
2011	1	0
2013	1	0
2015	4	0
2016	1	0
2018	2	0
2023	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K031556, 1983–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FLL device

#1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K841105	Multichannel 2000 Fluoroptic Thermomet Summary page 1 …ntended to monitor tissue temperatures during clinical procedures requiring temperature feedback. Predicate Devices Luxtron Multichannel 2000 Fluoroptic Thermometer K841105 Endocare Electronic Thermometer System K96 1365 URI Therm-X Model TX- 100 Multichannel Thermocouple K84338 1 Thermom…	Luxtron	1984	—
*	K961365	Endocare Electornic Thermometer System Summary page 1 …dures requiring temperature feedback. Predicate Devices Luxtron Multichannel 2000 Fluoroptic Thermometer K841105 Endocare Electronic Thermometer System K96 1365 URI Therm-X Model TX- 100 Multichannel Thermocouple K84338 1 Thermometry System Device Description The VivaThermTMTemperature M…	Endocare, Inc.	1996	—
*	K843381	Uri TX-100 Multichannel Thermocouple Summary page 1 …tron Multichannel 2000 Fluoroptic Thermometer K841105 Endocare Electronic Thermometer System K96 1365 URI Therm-X Model TX- 100 Multichannel Thermocouple K84338 1 Thermometry System Device Description The VivaThermTMTemperature Measurement System consists of a multi-channel electronic temp…	Uri Therm-X, Inc.	1984	—

What descends from it? (20)

See all 20

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K052919	Microsulis Tissue Ablation System	Microsulis Americas, Inc.	2006	15
K081042	Microthermx-100 Microwave Ablation System and Accessories	Bsd Medical Systems Corp.	2008	2
K060980	Vendys Model 5000 B/BC	Endothelix, Inc.	2007	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 13.2 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K052919 (Microsulis Americas, Inc., 2006) has gone furthest, with 15 descendants of its own.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLL

6in 2025

2007high 43 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLL

131in 2025

2007high 295 (2023) · low 59 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FLL

1in 2025

2007high 5 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FLL

73in 2025

2007high 142 (2022) · low 4 (2007)2025

MAUDE reports naming product code FLL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	15	81	0	4
2008	14	59	0	13
2009	13	84	0	9
2010	24	88	0	9
2011	20	113	1	18
2012	17	126	0	26
2013	14	149	0	16
2014	7	199	0	54
2015	3	270	1	53
2016	22	157	0	58
2017	16	174	2	118
2018	35	209	1	51
2019	22	198	5	52
2020	21	194	0	53
2021	43	218	0	115
2022	24	218	0	142
2023	17	295	0	101
2024	13	223	0	118
2025	6	131	1	73
2026	2	—	1	—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031556 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031556: Vivatherm Themperature Measurement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031556

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026