510(k) · Cleared
ClearedFetalgard 3000 Fetal Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Analogic Corp. · HGM System, Monitoring, Perinatal
Cleared on Aug 12, 1999 as substantially equivalent to K950420 (Analogic Corp., 1995) after a 321-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Aug 12, 1999
- Review
- 321 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950420 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK950420 Fetalgard 3000 - Models IP1, IP2, AP2 and AP3Analogic Corp. · 1995
- This deviceK983395 Fetalgard 3000 Fetal MonitorAnalogic Corp. · 1999
- Descendant · cites it directly · 2 of its ownK090145 Surecall Emg Labor MonitorReproductive Research Technologies, LP · 2011
- Descendant · 2 generations on · 0 of its ownK131889 Eum 100PROPromedic, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK130002 Surecall Labor MonitorReproductive Research Technologies, LP · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950420 | Fetalgard 3000 - Models IP1, IP2, AP2 and AP3 | Analogic Corp. | 1995 | — |
| 0 (this device) | K983395 | Fetalgard 3000 Fetal Monitor | Analogic Corp. | 1999 | — |
| +1 | K090145 | Surecall Emg Labor Monitor | Reproductive Research Technologies, LP | 2011 | — |
| +2 | K131889 | Eum 100PRO | Promedic, Inc. | 2014 | — |
| +2 | K130002 | Surecall Labor Monitor | Reproductive Research Technologies, LP | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (1)
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 |
|---|---|---|---|
| * | K950420 | Fetalgard 3000 - Models IP1, IP2, AP2 and AP3Summary page 2…The modified Fetalgard 3000 Fetal Monitor is nearly identical to the predicate Fetalgard 3000 Fetal Monitor which was cleared for marketing under Premarket Notification K950420. The tocotonometer has been redesigned using the same principle of operation, with changes in the design details to enhance reli… | 1995 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090145 | Surecall Emg Labor Monitor | 2011 | 2 |
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?
- Its one ancestor has no recall.
- Of its descendants, K090145 (Reproductive Research Technologies, LP, 2011) has gone furthest, with 2 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?
The Fetalgard 3000 Fetal Monitor is a Perinatal Monitoring System for showing graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating display of uterine contraction and fetal heart rate measurements. This data is intended to aid in assessing the well-being of the fetus during pregnancy, labor, and delivery.
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/K983395 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983395: Fetalgard 3000 Fetal Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983395
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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