510(k) · Cleared
ClearedCorometrics Model 173 Fetal Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · HGM System, Monitoring, Perinatal
Cleared on Feb 2, 2000 as substantially equivalent to K991905 (General Electric Medical Systems Information Techn, 1999) after an 89-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Feb 2, 2000
- Review
- 89 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K852608 (1985). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK852608 Spectra 400 Extended Surveillance & Alert SystemGe Medical Systems Information Technologies · 1985
- 1 generation backK991905 Corometrics Model 171 and 172 Fetal MonitorGeneral Electric Medical Systems Information Techn · 1999
- This deviceK993751 Corometrics Model 173 Fetal MonitorGe Medical Systems Information Technologies · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852608 | Spectra 400 Extended Surveillance & Alert System | Ge Medical Systems Information Technologies | 1985 | — |
| −1 | K991905 | Corometrics Model 171 and 172 Fetal Monitor | General Electric Medical Systems Information Techn | 1999 | — |
| 0 (this device) | K993751 | Corometrics Model 173 Fetal Monitor | Ge Medical Systems Information Technologies | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K923207 | Corometrics Model 151 Fetal Monitor Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…fication of Legally Marketed Equivalent Devices (Predicate Systems). Predicate System Manufacturer KN um@' _] Corometrics Model 151 GE Marquette Medical Systems, Inc. | k9232077, clearance Fetal Monitor 61 Barnes Park Road North date: 3/31/94 Corometrics Models 171 | GE Marquette Medical Systems, Inc. | K… | |
| * | K991905 | Corometrics Model 171 and 172 Fetal MonitorSummary page 1…Marquette Medical Systems, Inc. | k9232077, clearance Fetal Monitor 61 Barnes Park Road North date: 3/31/94 Corometrics Models 171 | GE Marquette Medical Systems, Inc. | K991905, clearance & 172 Fetal Monitors 61 Barnes Park Road North date: 9/1/99 [807.92(a)4 & 807.92(a)5] Device Description & Intended U… | 1999 |
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 15 years and passes through 2 companies; a new generation was cleared every 13.9 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K991905.
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 173 Series Monitor is used for monitoring of the fetus throughout labor and delivery (i.e. fetal heart rate via US Transducer, fetal ECG via Spiral Electrode and uterine activity monitoring via TOCO Transducer or [UPC). 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/K993751 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993751: Corometrics Model 173 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/K993751
Report an extraction error
Are you the manufacturer?
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