510(k) · Cleared
ClearedPUREtrace™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nemo Healthcare BV · OSP Uterine Electromyographic Monitor
Cleared on Feb 7, 2017 as substantially equivalent to K112390 (Monica Healthcare, Ltd., 2012) after a 455-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Feb 7, 2017
- Review
- 455 days
- Class
- Class II
- Product code
- OSP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K900480 (1990). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (1)
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 |
|---|---|---|---|
| * | K112390 | Monica AN24Summary page 4…II Product code: OSP, uterine electromyographic monitor Predicate Device: Monica Healthcare AN24 (K112390) Device Description: PUREtrace is a device for registering the electrical activity of the uterine muscle (myometrium) of labori… | 2012 |
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 27 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K112390.
How does its category compare?
All OSP devicesOSP Uterine Electromyographic Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
PUREtrace™ is an electromyography (EMG) device that non-invasively measures intrapartum uterine activity. PUREtrace™ is indicated for use on women who are at term (≥37 completed weeks), in labor, with singleton pregnancies. The signal is acquired from surface electrodes that are placed on the maternal abdomen. PUREtrace™ is intended for use by healthcare professionals in a clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153262: PUREtrace™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153262
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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