510(k) · Cleared
ClearedSurecall Emg Labor Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reproductive Research Technologies, LP · OSP Uterine Electromyographic Monitor
Cleared on Jan 25, 2011 as substantially equivalent to K013477 (Ventrex, Inc., 2002) and 1 other predicate after a 734-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Jan 25, 2011
- Review
- 734 days
- Class
- Class II
- Product code
- OSP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K950420 (1995). 5 ancestors in all, the oldest K843385 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK950420 Fetalgard 3000 - Models IP1, IP2, AP2 and AP3Analogic Corp. · 1995
- 1 generation backK983395 Fetalgard 3000 Fetal MonitorAnalogic Corp. · 1999
- This deviceK090145 Surecall Emg Labor MonitorReproductive Research Technologies, LP · 2011
- Descendant · cites it directly · 0 of its ownK131889 Eum 100PROPromedic, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK130002 Surecall Labor MonitorReproductive Research Technologies, LP · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950420 | Fetalgard 3000 - Models IP1, IP2, AP2 and AP3 | Analogic Corp. | 1995 | — |
| −1 | K983395 | Fetalgard 3000 Fetal Monitor | Analogic Corp. | 1999 | — |
| 0 (this device) | K090145 | Surecall Emg Labor Monitor | Reproductive Research Technologies, LP | 2011 | — |
| +1 | K131889 | Eum 100PRO | Promedic, Inc. | 2014 | — |
| +1 | K130002 | Surecall Labor Monitor | Reproductive Research Technologies, LP | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K013477 | Toco Lite, Model TD-01Summary page 1…ber: 884.2720 Product Code: OSP 3. Predicate Devices: Toco Lite Model TD-01 [K01 3477] Fetalgard 3000 Fetal Monitor [K9833951… | 2002 |
| * | K983395 | Fetalgard 3000 Fetal MonitorSummary page 1…Product Code: OSP 3. Predicate Devices: Toco Lite Model TD-01 [K01 3477] Fetalgard 3000 Fetal Monitor [K9833951 Section 5 510(k) Submission Page 1 02011 Reprod… | 1999 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 2 companies; a new generation was cleared every 11.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K131889 (Promedic, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K013477.
How does its category compare?
All OSP devicesOSP Uterine Electromyographic Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 SureCALL® EMG Labor Monitor® is a transabdominal electromyography (EMG) monitor intended to measure intrapartum uterine activity. It is intended for use on women who are at term (>36 completed weeks), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.
The device is intended for use by healthcare professionals in a clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090145: Surecall Emg Labor Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090145
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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