510(k) · Cleared
ClearedEum 100PRO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promedic, Inc. · OSP Uterine Electromyographic Monitor
Cleared on Apr 23, 2014 as substantially equivalent to K090145 (Reproductive Research Technologies, LP, 2011) and 1 other predicate after a 302-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Apr 23, 2014
- Review
- 302 days
- Class
- Class II
- Product code
- OSP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K950420 (1995). 8 ancestors in all, the oldest K843385 (1984). No later device cites it as a predicate yet.
- Root · 3 generations backK950420 Fetalgard 3000 - Models IP1, IP2, AP2 and AP3Analogic Corp. · 1995
- 2 generations backK983395 Fetalgard 3000 Fetal MonitorAnalogic Corp. · 1999
- 1 generation backK090145 Surecall Emg Labor MonitorReproductive Research Technologies, LP · 2011
- This deviceK131889 Eum 100PROPromedic, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950420 | Fetalgard 3000 - Models IP1, IP2, AP2 and AP3 | Analogic Corp. | 1995 | — |
| −2 | K983395 | Fetalgard 3000 Fetal Monitor | Analogic Corp. | 1999 | — |
| −1 | K090145 | Surecall Emg Labor Monitor | Reproductive Research Technologies, LP | 2011 | — |
| 0 (this device) | K131889 | Eum 100PRO | Promedic, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2012 | 1 | 0 |
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 OSP? 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 OSP device
- #1 K190798 LaborView™ LV1000 Wireless Electrode Systemscore 0.9 · 4 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090145 | Surecall Emg Labor MonitorSummary page 1…al uterine contraction monitor OSP - CFR 884.2720 Class 11 Predicate Devices: K090145 - RRT -SureCALL® KI 12390 - Monica Healthcare - AN24 Device Description: The EUM IOOPro Sys… | 2011 |
| * | K112390 | Monica AN24Summary page 4…21-Apr- 14 Discussion - This is identical to the predicates, except that the EUM I GO11ro does not monitor additional features, i.e., FHR, MHR as does K 112390 -Monica AN24, nor does it connect to other traditional sensors which can be displayed on its screen as does K090… | 2012 |
| † | K990356 | The Bagnoli-8 Emg System | 1999 |
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 19 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K090145.
How does its category compare?
All OSP devicesOSP Uterine Electromyographic Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OSP
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · OSP
220in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OSP
No recall names OSP since 2007.
Adverse event reports per year · OSP
1in 2025
MAUDE reports naming product code OSP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 220 | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EUM I OOPro (Electro Uterine Monitor) is a transabdominal electromyography (EMG) monitor intended to non-invasively measure intrapartum uterine activity. The EUM I QOPro acquires the signal from surface EMG electrodes placed on the patient abdomen.
The EUM IOOPro is intended for use on women in term (>36 completed weeks of gestation) labor, with singleton pregnancies.
The EUM IOOPro is intended for use by healthcare professionals in a clinical setting.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131889 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131889: Eum 100PRO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131889
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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