510(k) · Cleared

Cleared

Laborpro System

K081984510(k) TraditionalCleared Mar 4, 2009236-day reviewClass II21 CFR 884.2800

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

Trig Medical, Ltd. · NPB System, Monitoring, For Progress Of Labor

Cleared on Mar 4, 2009 as substantially equivalent to DEN060006 (Barnev, Ltd., 2007) and 1 other predicate after a 236-day review. Its family tree reaches back 3 generations to 1988.

Decided: Mar 4, 2009
Review: 236 days
Class: Class II
Product code: NPB
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K882383 (1988). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK882383 Maggi Series Ultra. Needle, Biopsy/Catheter GuidesCIVCO Medical Instruments Co., Inc. · 1988
2 generations backK974432 Ultraguide 1000Ultraguide, Ltd. · 1998
1 generation backK023227 USG 2000SAUltraguide, Ltd. · 2002
This deviceK081984 Laborpro SystemTrig Medical, Ltd. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K882383	Maggi Series Ultra. Needle, Biopsy/Catheter Guides	CIVCO Medical Instruments Co., Inc.	1988	—
−2	K974432	Ultraguide 1000	Ultraguide, Ltd.	1998	—
−1	K023227	USG 2000SA	Ultraguide, Ltd.	2002	—
0 (this device)	K081984	Laborpro System	Trig Medical, Ltd.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1995	1	0
2007	1	0

FIG. 1 — Lineage of K081984, 1988–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 NPB? 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

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	DEN060006	Computerized Labor Monitoring System Our reading of the summary gave K060028, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN060006, Computerized Labor Monitoring System (Barnev, Ltd.), granted Jan 30, 2007; older De Novo requests were first filed under a 510(k) number, so this links to the grant.	Barnev, Ltd.	2007	—
*	K023227	USG 2000SA Summary page 1 …cate Devices: 1. The Computerized Labor Monitoring (CLM) System (Barney Ltd.), cleared under K060028. 2. USG 2000sa (UltraGuide Ltd.), cleared under K023227 5.12 Intended Use / Indication for Use: The LaborPro System is intended for monitoring the active phase of labor in womenwit…	Ultraguide, Ltd.	2002	—
*	—	pelvimeters Named without a submission number			—
*	—	Cervilenz Measuring Sound Named without a submission number			—

Also cleared against DEN060006: 1 other device →

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 21 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
None of the 6 ancestors has a recall.
1 other device also cites its predicate DEN060006.

How does its category compare?

All NPB devices

NPB System, Monitoring, For Progress Of Labor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NPB

2in 2009

2007high 2 (2009) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NPB

Too few NPB 510(k)s in any year since 2007 to give a median.

Recalls per year · NPB

No recall names NPB since 2007.

Adverse event reports per year · NPB

No MAUDE report names NPB since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	1	—	0
2009	2	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

Read the full statement (109 words)

The LaborPro System is intended for monitoring the active phase of labor in women with term gestations and a singleton fetus in vertex presentation. The device intermittently assesses fetal head station, position and cervical dilation. Cervical dilation using LaborPro is assessed using position sensors during vaginal examination. The LaborPro also may be used to measure cervical length, pubic arch angle and interspinous diameter using position sensors during vaginal examination. The LaborPro combines a magnetic tracking system including a transmitter and position sensor with an ultrasound imaging system (not included with the LaborPro). Measurements are displayed numerically and graphically as a function of time to show the progress of labor.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081984 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081984: Laborpro System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081984

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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