510(k) · Cleared
ClearedCorometrics Model 171 and 172 Fetal Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Medical Systems Information Techn · HGM System, Monitoring, Perinatal
Cleared on Sep 1, 1999 as substantially equivalent to K920376 (Ge Medical Systems Information Technologies, 1992) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1985. 16 later devices descend from it.
- Decided
- Sep 1, 1999
- Review
- 89 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K852608 (1985). 2 ancestors in all. 16 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK852608 Spectra 400 Extended Surveillance & Alert SystemGe Medical Systems Information Technologies · 1985
- This deviceK991905 Corometrics Model 171 and 172 Fetal MonitorGeneral Electric Medical Systems Information Techn · 1999
- Descendant · cites it directly · 12 of its ownK040903 Cadence, Models 2001 and 2002Edan Instruments, Inc. · 2004
- Descendant · 2 generations on · 11 of its ownK073221 Cadence IIEdan Instruments, Inc. · 2007
- Descendant · 3 generations on · 6 of its ownK082602 Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc. · 2008
- Descendant · 4 generations on · 5 of its ownK100797 Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010
- Descendant · 2 generations on · 4 of its ownK082369 Cadence, Cadence Dual, Cadence II Fetal MonitorEdan Instruments, Inc. · 2008
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K040903Cadence, Models 2001 and 2002Edan Instruments, Inc. · 2004 · cites it directly12descendants
- K073221Cadence IIEdan Instruments, Inc. · 2007 · 2 generations on11descendants
- K082602Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc. · 2008 · 3 generations on6descendants
- K100797Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010 · 4 generations on5descendants
- K082369Cadence, Cadence Dual, Cadence II Fetal MonitorEdan Instruments, Inc. · 2008 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852608 | Spectra 400 Extended Surveillance & Alert System | Ge Medical Systems Information Technologies | 1985 | — |
| 0 (this device) | K991905 | Corometrics Model 171 and 172 Fetal Monitor | General Electric Medical Systems Information Techn | 1999 | — |
| +1 | K040903 | Cadence, Models 2001 and 2002 | Edan Instruments, Inc. | 2004 | — |
| +2 | K073221 | Cadence II | Edan Instruments, Inc. | 2007 | — |
| +3 | K082602 | Fetal & Maternal Monitor, Model F6, F9 | Edan Instruments, Inc. | 2008 | — |
| +4 | K100797 | Fetal Maternal Monitor Model F9 Express and Express | Edan Instruments, Inc. | 2010 | — |
| +2 | K082369 | Cadence, Cadence Dual, Cadence II Fetal Monitor | Edan Instruments, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 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 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? (2)
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 |
|---|---|---|---|
| * | K920376 | Corometrics Model 150 Fetal MonitorSummary page 1…ice. [807.92(a)3]_1dentification of Legally Marketed Equivalent Devices (Predicate Systems). Coromecs Modél 50 and Alert Systems GE Marquette Medical Systems, Inc. | k920376, clearance Fetal Monitor 61 Bames Park Road North date: 4/27/92 Corometrics Spectra 400 | GE Marquette Medical Systems, Inc. | K8… | 1992 |
| * | K852608 | Spectra 400 Extended Surveillance & Alert SystemSummary page 1…Marquette Medical Systems, Inc. | k920376, clearance Fetal Monitor 61 Bames Park Road North date: 4/27/92 Corometrics Spectra 400 | GE Marquette Medical Systems, Inc. | K852608, clearance Extended Surveillance 61 Bames Park Road North date: 9/29/85 [807.92(a)4 & 807.92(a)S] Device Description & Intended… | 1985 |
What descends from it? (16)
See all 163 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K040903 (Edan Instruments, Inc., 2004) has gone furthest, with 12 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 | — |
What is it indicated for?
I. Fetal Surveillance
The Corometrics® Model 171/172 Series Monitors are used for monitoring of the fetus during the antepartum period as well as throughout labor and delivery (i.c. fetal heart rate and uterine activity monitoring). The device also has an optional monitoring mode to detect fetal body movements.
II. Maternal NBP Recording
Blood Pressure. The monitor has an interface to select external NBP monitors. The Monitor does not process any NBP data but only prints the NBP data, from the external monitor, to its chart recorder.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991905 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991905: Corometrics Model 171 and 172 Fetal Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991905
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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