510(k) · Cleared
ClearedClinical Infor Syst (Cis) W/Fetal Monit Remote Disp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinicomp, Inc. · HGM System, Monitoring, Perinatal
Cleared on Mar 29, 1995 after a 754-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.
- Decided
- Mar 29, 1995
- Review
- 754 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 2 citing it directly.
- This deviceK931133 Clinical Infor Syst (Cis) W/Fetal Monit Remote DispClinicomp, Inc. · 1995
- Descendant · cites it directly · 18 of its ownK960109 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1996
- Descendant · 2 generations on · 10 of its ownK963608 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1997
- Descendant · 2 generations on · 9 of its ownK993008 Quantitative Sentinel SystemMarquette Medical Systems, Inc. · 1999 · Recalled
- Descendant · cites it directly · 4 of its ownK051175 Civ-OB Obstrical Monitoring Software ApplicationCivent Communications, Ltd. · 2006
- Descendant · 2 generations on · 3 of its ownK103172 Civ-OB (Plus)Civnet Communication, Ltd. · 2011
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K960109Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1996 · cites it directly18descendants
- K963608Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1997 · 2 generations on10descendants
- K993008Quantitative Sentinel SystemMarquette Medical Systems, Inc. · 1999 · 2 generations on9descendants
- K051175Civ-OB Obstrical Monitoring Software ApplicationCivent Communications, Ltd. · 2006 · cites it directly4descendants
- K103172Civ-OB (Plus)Civnet Communication, Ltd. · 2011 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931133 | Clinical Infor Syst (Cis) W/Fetal Monit Remote Disp | Clinicomp, Inc. | 1995 | — |
| +1 | K960109 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1996 | — |
| +2 | K963608 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1997 | — |
| +2 | K993008 | Quantitative Sentinel System | Marquette Medical Systems, Inc. | 1999 | 3 |
| +1 | K051175 | Civ-OB Obstrical Monitoring Software Application | Civent Communications, Ltd. | 2006 | — |
| +2 | K103172 | Civ-OB (Plus) | Civnet Communication, Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) 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 HGM? 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 HGM device
- #1 K241882 Fetal & Maternal Monitor (F15A, F15A Air)score 19.5 · 33 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (19)
See all 192 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, K960109 (Quantitative Medicine, Inc., 1996) has gone furthest, with 18 descendants of its own.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HGM
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HGM
269in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HGM
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HGM
99in 2025
MAUDE reports naming product code HGM, 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 | 3 | 56 | 0 | 35 |
| 2008 | 4 | 75 | 4 | 17 |
| 2009 | 4 | 66 | 6 | 42 |
| 2010 | 4 | 193 | 0 | 64 |
| 2011 | 13 | 141 | 0 | 83 |
| 2012 | 4 | 107 | 0 | 44 |
| 2013 | 2 | — | 1 | 16 |
| 2014 | 4 | 231 | 1 | 30 |
| 2015 | 5 | 169 | 0 | 44 |
| 2016 | 1 | — | 0 | 17 |
| 2017 | 3 | 138 | 0 | 27 |
| 2018 | 3 | 258 | 0 | 30 |
| 2019 | 0 | — | 5 | 41 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 71 |
| 2022 | 1 | — | 0 | 87 |
| 2023 | 2 | — | 0 | 69 |
| 2024 | 1 | — | 0 | 174 |
| 2025 | 4 | 269 | 0 | 99 |
| 2026 | 2 | — | 2 | — |
https://510kreport.com/device/K931133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K931133: Clinical Infor Syst (Cis) W/Fetal Monit Remote Disp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931133
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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