510(k) Report

510(k) · Cleared

Cleared

Uroval BRS System, Model BRS01; Telesis, Model PROMO1

K083679510(k) TraditionalCleared Sep 11, 2009274-day reviewClass II21 CFR 890.1375

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

Uroval · IKN Electromyograph, Diagnostic

Cleared on Sep 11, 2009 as substantially equivalent to K000220 (Motion Lab Systems, Inc., 2000) and 1 other predicate after a 274-day review. Its family tree reaches back 1 generation to 2000.

Decided
Sep 11, 2009
Review
274 days
Class
Class II
Product code
IKN
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K000220 (2000). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorK000220 · MA-300 Electromyography System · Motion Lab Systems, Inc. · 2000200020022004200620082010
Other ancestors, by generation 1 generation back: 1 other ancestor K000220 · MA-300 Electromyography System · Motion Lab Systems, Inc. · 20000
  1. Root · 1 generation backK000220 MA-300 Electromyography SystemMotion Lab Systems, Inc. · 2000
  2. This deviceK083679 Uroval BRS System, Model BRS01; Telesis, Model PROMO1Uroval · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000220MA-300 Electromyography SystemMotion Lab Systems, Inc.2000—
0 (this device)K083679Uroval BRS System, Model BRS01; Telesis, Model PROMO1Uroval2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K083679, 2000–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K000220MA-300 Electromyography System
Summary page 1
…Predicate Devices The UroVal BRS System is substantially equivalent in intended use, function and basic composition to the currently marketed MLS MA-300 System (K000220), and The Prometheus Group CTS 2000 System (KO0l1515). Device Description The UroVal BRS System is used to record an…
Motion Lab Systems, Inc.2000—
*K001515Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000The Prometheus Group2000—

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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All IKN devices

IKN Electromyograph, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · IKN

3in 2017

2007: 12008: 12009: 12011: 22012: 12013: 22014: 12015: 12017: 3
2007high 3 (2017) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IKN

188in 2017

2017: 188 days median
2007high 188 (2017)2026

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

Recalls per year · IKN

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · IKN

3in 2025

2009: 22010: 12011: 42012: 42013: 242014: 32015: 132016: 112017: 22018: 52019: 62020: 12021: 22022: 22024: 12025: 3
2007high 24 (2013) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20081—00
20091—02
20100—11
20112—04
20121—04
20132—024
20141—03
20151—013
20160—011
2017318802
20180—05
20190—06
20200—01
20210—02
20220—02
20230—00
20240—01
20250—03
20260—0—

What is it indicated for?

To acquire EMG signals for display and analysis by, or under the direction of a health care professional, to assess neurogenic sacral dysfunction such as urinary incontinence and fecal incontinence.

Indications for use as stated in the FDA summary.

Recent decisions in IKN

The IKN category page

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  • K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc. · 2017
  • K142494ViMoveDorsavi, Ltd. · 2015
  • K131094VimoveDorsa VI Pty., Ltd. · 2014

https://510kreport.com/device/K083679 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083679: Uroval BRS System, Model BRS01; Telesis, Model PROMO1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083679

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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