510(k) · Cleared

Cleared

Vendys Model 5000 B/BC

K060980510(k) TraditionalCleared Aug 16, 2007493-day reviewClass II21 CFR 870.1425

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

Endothelix, Inc. · DQK Computer, Diagnostic, Programmable

Cleared on Aug 16, 2007 as substantially equivalent to K031556 (Vivant Medical, Inc., 2003) and 3 other predicates after a 493-day review. Its family tree reaches back 3 generations to 1983.

Decided: Aug 16, 2007
Review: 493 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K830592 (1983). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK830592 Dispos. Type T Thermocouple Temp.ProbeElectromedics, Inc. · 1983
2 generations backK961365 Endocare Electornic Thermometer SystemEndocare, Inc. · 1996
1 generation backK031556 Vivatherm Themperature Measurement SystemVivant Medical, Inc. · 2003
This deviceK060980 Vendys Model 5000 B/BCEndothelix, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K830592	Dispos. Type T Thermocouple Temp.Probe	Electromedics, Inc.	1983	—
−2	K961365	Endocare Electornic Thermometer System	Endocare, Inc.	1996	—
−1	K031556	Vivatherm Themperature Measurement System	Vivant Medical, Inc.	2003	—
0 (this device)	K060980	Vendys Model 5000 B/BC	Endothelix, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1984	2	0
2001	1	0
2003	1	0

FIG. 1 — Lineage of K060980, 1983–2007Source: 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 DQK? 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 DQK device

#1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 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? (4)

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
*	K031556	Vivatherm Themperature Measurement System Summary page 1 …cular Predicate Devices Manufacturer Device Approval No. Vivant Medical VivaTherm Temp Monitor Sys K031556 Endocare, Inc. Endocare Electronic Therm Sys K961365 URI Therm-X, Inc URI TX-100 Multi Chan Thenno…	Vivant Medical, Inc.	2003	—
*	K961365	Endocare Electornic Thermometer System Summary page 1 …Approval No. Vivant Medical VivaTherm Temp Monitor Sys K031556 Endocare, Inc. Endocare Electronic Therm Sys K961365 URI Therm-X, Inc URI TX-100 Multi Chan Thenno K843381 Itamar Medical Endo PAT 2000…	Endocare, Inc.	1996	—
*	K843381	Uri TX-100 Multichannel Thermocouple Summary page 1 …rm Temp Monitor Sys K031556 Endocare, Inc. Endocare Electronic Therm Sys K961365 URI Therm-X, Inc URI TX-100 Multi Chan Thenno K843381 Itamar Medical Endo PAT 2000 K032519…	Uri Therm-X, Inc.	1984	—
*	K032519	Endo Pat 2000 Summary page 1 …e Electronic Therm Sys K961365 URI Therm-X, Inc URI TX-100 Multi Chan Thenno K843381 Itamar Medical Endo PAT 2000 K032519 PAGE 6.1…	Itamar Medical	2003	—

Also cleared against K031556: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 24 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
None of the 7 ancestors has a recall.
2 other devices also cite its predicate K031556.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DQK

23so far in 2026, the most since 2007

2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007high 190 (2016) · low 64 (2010)2026

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

Recalls per year · DQK

1in 2025

2007high 24 (2024) · low 0 (2016)2026

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

Adverse event reports per year · DQK

433in 2025

2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, 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	13	83	4	18
2008	4	70	1	34
2009	12	93	2	40
2010	9	64	3	49
2011	12	69	2	55
2012	7	74	3	129
2013	13	68	1	180
2014	9	90	4	115
2015	7	125	2	131
2016	15	190	0	340
2017	7	146	2	252
2018	14	150	6	261
2019	15	113	1	218
2020	16	123	1	215
2021	16	132	1	351
2022	19	136	2	319
2023	21	133	2	340
2024	13	100	24	557
2025	22	95	1	433
2026	23	151	2	—

What is it indicated for?

The VENDYS Model 5000 B/BC is a non-invasive, digital temperature monitoring device. The device provides continuous monitoring of body surface temperature at multiple sites simultaneously (e.g. fingertips on the study and control hands).

It is intended to use for measurement of vascular reactivity by monitoring temperature changes before, during and after a reactive hyperemia test using a 2-5 minute cuff occlusion procedure.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060980 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060980: Vendys Model 5000 B/BC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060980

Report an extraction error

Are you the manufacturer?

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