510(k) · Cleared
ClearedBirthtrack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barnev, Ltd. · NPB System, Monitoring, For Progress Of Labor
Cleared on Jul 8, 2008 as substantially equivalent to DEN060006 (Barnev, Ltd., 2007) and 2 other predicates after a 120-day review. Its family tree reaches back 2 generations to 1977. 5 later devices descend from it.
- Decided
- Jul 8, 2008
- Review
- 120 days
- Class
- Class II
- Product code
- NPB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K771553 (1977). 8 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK771553 Spiral Scalp Electrode, 14499AHewlett-Packard Co. · 1977
- 1 generation backK030691 Fetal Spiral Electrode, Model FSE07000Clinical Innovations, Inc. · 2003 · Recalled
- This deviceK080672 BirthtrackBarnev, Ltd. · 2008
- Descendant · cites it directly · 4 of its ownK082704 Birthtrack (a.K.a. CLM)Barnev, Ltd. · 2009
- Descendant · 2 generations on · 3 of its ownK103172 Civ-OB (Plus)Civnet Communication, Ltd. · 2011
- Descendant · 3 generations on · 1 of its ownK143695 Central Monitoring SystemEdan Instruments, Inc. · 2015
- Descendant · 4 generations on · 0 of its ownK171178 Central Monitoring SystemEdan Instruments, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK153580 Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd. · 2016
Most influential descendants
Showing 5 of 5 · See all- K082704Birthtrack (a.K.a. CLM)Barnev, Ltd. · 2009 · cites it directly4descendants
- K103172Civ-OB (Plus)Civnet Communication, Ltd. · 2011 · 2 generations on3descendants
- K143695Central Monitoring SystemEdan Instruments, Inc. · 2015 · 3 generations on1descendant
- K171178Central Monitoring SystemEdan Instruments, Inc. · 2017 · 4 generations on0descendants
- K153580Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771553 | Spiral Scalp Electrode, 14499A | Hewlett-Packard Co. | 1977 | — |
| −1 | K030691 | Fetal Spiral Electrode, Model FSE07000 | Clinical Innovations, Inc. | 2003 | 2 |
| 0 (this device) | K080672 | Birthtrack | Barnev, Ltd. | 2008 | — |
| +1 | K082704 | Birthtrack (a.K.a. CLM) | Barnev, Ltd. | 2009 | — |
| +2 | K103172 | Civ-OB (Plus) | Civnet Communication, Ltd. | 2011 | — |
| +3 | K143695 | Central Monitoring System | Edan Instruments, Inc. | 2015 | — |
| +4 | K171178 | Central Monitoring System | Edan Instruments, Inc. | 2017 | 1 |
| +3 | K153580 | Central Monitoring System | Guangdong Biolight Meditech Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 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
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | 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. | 2007 |
| * | K844608 | Surgicraft Copeland DisposableSummary page 1…l Spiral Sensor and the Cervical Sensor. - The Cervical Sensor is comparable to the Disposable FSE (K844608) manufactured by Surgicraft Copeland, and to the previous Cervical ITR (K060028) manufactured by Barnev.… | 1985 |
| * | K030691 | Fetal Spiral Electrode, Model FSE07000Summary page 2…Page 7-2 - The Fetal Spiral Sensor is comparable to the Disposable FSE (K030691) manufactured by Clinical Innovations, and to the previous Fetal ITR (K060028) manufactured by Barney.… | 2003 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082704 | Birthtrack (a.K.a. CLM) | 2009 | 4 |
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 31 years and passes through 3 companies; a new generation was cleared every 26.1 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K082704 (Barnev, Ltd., 2009) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate DEN060006.
How does its category compare?
All NPB devicesNPB System, Monitoring, For Progress Of Labor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NPB
2in 2009
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BirthTrack System is an ultrasound device intended to be
used for monitoring the active phase of labor in women with
term pregnancies, vertex presentation, and ruptured membranes.
It is intended to be placed when cervical dilation is between 3
cm and 7 cm. The device continuously measures cervical
dilation and fetal head station with ultrasound transducers
attached to the maternal abdomen and cervix and to the fetal
scalp. These 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/K080672 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080672: Birthtrack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080672
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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