510(k) · Cleared
ClearedLaborView™ LV1000 Wireless Electrode System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Obmedical Company · OSP Uterine Electromyographic Monitor
Cleared on Sep 18, 2020 as substantially equivalent to K142583 (Obmedical Company, 2015) after a 540-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Sep 18, 2020
- Review
- 540 days
- Class
- Class II
- Product code
- OSP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K900480 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK900480 M1350A Fetal Monitor (Intrapartum)Hewlett-Packard Co. · 1990
- 3 generations backK954351 Series 50XMHewlett-Packard GmbH · 1996
- 2 generations backK112390 Monica AN24Monica Healthcare, Ltd. · 2012
- 1 generation backK142583 LaborView LV1000Obmedical Company · 2015
- This deviceK190798 LaborView™ LV1000 Wireless Electrode SystemObmedical Company · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K900480 | M1350A Fetal Monitor (Intrapartum) | Hewlett-Packard Co. | 1990 | — |
| −3 | K954351 | Series 50XM | Hewlett-Packard GmbH | 1996 | — |
| −2 | K112390 | Monica AN24 | Monica Healthcare, Ltd. | 2012 | — |
| −1 | K142583 | LaborView LV1000 | Obmedical Company | 2015 | — |
| 0 (this device) | K190798 | LaborView™ LV1000 Wireless Electrode System | Obmedical Company | 2020 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K142583 | LaborView LV1000Summary page 4…m, monitoring, perinatal Regulatory Class: Class II Review Panel: Obstetrics/Gynecology Predicate Device: K142583 Manufacturer: OB Medical Device Name: LaborView LV1000… | 2015 |
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 30 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All OSP devicesOSP Uterine Electromyographic Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 LaborView ™ LV1000 Wireless Electrode System is a transabdominal electromyography and electrocardiography intrapartum maternal-fetal sensor. It works non-invasively via surface electrodes on the maternal abdomen with appropriate monitors to measure fetal heart rate (FHR), uterine activity (UA), and maternal heart rate (MHR). It is indicated for use on women who are at term (>36 completed weeks), in labor, with singleton pregnancies. It is intended for use by a healthcare professional in a clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190798 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190798: LaborView™ LV1000 Wireless Electrode System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190798
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