De Novo · Granted
GrantedComputerized Labor Monitoring System
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
Granted on Jan 30, 2007 as a new device type through De Novo after a 104-day review. 7 later devices descend from it.
- Decided
- Jan 30, 2007
- Review
- 104 days
- Class
- Class II
- Product code
- NPB
- Recalls
- None
7 later devices descend from it, 2 citing it directly.
- This deviceDEN060006 Computerized Labor Monitoring SystemBarnev, Ltd. · 2007
- Descendant · cites it directly · 5 of its ownK080672 BirthtrackBarnev, Ltd. · 2008
- Descendant · 2 generations on · 4 of its ownK082704 Birthtrack (a.K.a. CLM)Barnev, Ltd. · 2009
- Descendant · 3 generations on · 3 of its ownK103172 Civ-OB (Plus)Civnet Communication, Ltd. · 2011
- Descendant · 4 generations on · 1 of its ownK143695 Central Monitoring SystemEdan Instruments, Inc. · 2015
- Descendant · 5 generations on · 0 of its ownK171178 Central Monitoring SystemEdan Instruments, Inc. · 2017 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K080672BirthtrackBarnev, Ltd. · 2008 · cites it directly5descendants
- K082704Birthtrack (a.K.a. CLM)Barnev, Ltd. · 2009 · 2 generations on4descendants
- K103172Civ-OB (Plus)Civnet Communication, Ltd. · 2011 · 3 generations on3descendants
- K143695Central Monitoring SystemEdan Instruments, Inc. · 2015 · 4 generations on1descendant
- K171178Central Monitoring SystemEdan Instruments, Inc. · 2017 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN060006 | Computerized Labor Monitoring System | Barnev, Ltd. | 2007 | — |
| +1 | K080672 | Birthtrack | Barnev, Ltd. | 2008 | — |
| +2 | K082704 | Birthtrack (a.K.a. CLM) | Barnev, Ltd. | 2009 | — |
| +3 | K103172 | Civ-OB (Plus) | Civnet Communication, Ltd. | 2011 | — |
| +4 | K143695 | Central Monitoring System | Edan Instruments, Inc. | 2015 | — |
| +5 | K171178 | Central Monitoring System | Edan Instruments, Inc. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (7)
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?
- Of its descendants, K080672 (Barnev, Ltd., 2008) has gone furthest, with 5 descendants of its own.
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. 2007, 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 | — |
https://510kreport.com/device/DEN060006 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN060006: Computerized Labor Monitoring System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN060006
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026