510(k) · Cleared
ClearedFetalgard 3000 - Models IP1, IP2, AP2 and AP3
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 May 15, 1995 after a 104-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 15, 1995
- Review
- 104 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK950420 Fetalgard 3000 - Models IP1, IP2, AP2 and AP3Analogic Corp. · 1995
- Descendant · cites it directly · 3 of its ownK983395 Fetalgard 3000 Fetal MonitorAnalogic Corp. · 1999
- Descendant · 2 generations on · 2 of its ownK090145 Surecall Emg Labor MonitorReproductive Research Technologies, LP · 2011
- Descendant · 3 generations on · 0 of its ownK131889 Eum 100PROPromedic, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK130002 Surecall Labor MonitorReproductive Research Technologies, LP · 2013
Most influential descendants
Showing 4 of 4 · See all- K983395Fetalgard 3000 Fetal MonitorAnalogic Corp. · 1999 · cites it directly3descendants
- K090145Surecall Emg Labor MonitorReproductive Research Technologies, LP · 2011 · 2 generations on2descendants
- K131889Eum 100PROPromedic, Inc. · 2014 · 3 generations on0descendants
- K130002Surecall Labor MonitorReproductive Research Technologies, LP · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950420 | Fetalgard 3000 - Models IP1, IP2, AP2 and AP3 | Analogic Corp. | 1995 | — |
| +1 | K983395 | Fetalgard 3000 Fetal Monitor | Analogic Corp. | 1999 | — |
| +2 | K090145 | Surecall Emg Labor Monitor | Reproductive Research Technologies, LP | 2011 | — |
| +3 | K131889 | Eum 100PRO | Promedic, Inc. | 2014 | — |
| +3 | K130002 | Surecall Labor Monitor | Reproductive Research Technologies, LP | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983395 | Fetalgard 3000 Fetal Monitor | 1999 | 3 |
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, K983395 (Analogic Corp., 1999) has gone furthest, with 3 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/K950420 · printed Nov 5, 2026
Cite this page
510(k) Report. “K950420: Fetalgard 3000 - Models IP1, IP2, AP2 and AP3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K950420
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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