510(k) · Cleared
ClearedFetalgard Lite
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 Nov 9, 2000 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Nov 9, 2000
- Review
- 87 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK002503 Fetalgard LiteAnalogic Corp. · 2000
- Descendant · cites it directly · 1 of its ownK043598 FC 1400 Fetal MonitorBionet Co., Ltd. · 2005
- Descendant · 2 generations on · 0 of its ownK123335 Sunray Fetal MonitorSunray Medical Apparatus Co., Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK051903 Fetalgard Lite-Nibp, Model FGL-NibpAnalogic Corporation · 2005
- Descendant · cites it directly · 0 of its ownK050234 Remote CareE.Care Solutions, Inc. · 2005
Most influential descendants
Showing 4 of 4 · See all- K043598FC 1400 Fetal MonitorBionet Co., Ltd. · 2005 · cites it directly1descendant
- K123335Sunray Fetal MonitorSunray Medical Apparatus Co., Ltd. · 2013 · 2 generations on0descendants
- K051903Fetalgard Lite-Nibp, Model FGL-NibpAnalogic Corporation · 2005 · cites it directly0descendants
- K050234Remote CareE.Care Solutions, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002503 | Fetalgard Lite | Analogic Corp. | 2000 | — |
| +1 | K043598 | FC 1400 Fetal Monitor | Bionet Co., Ltd. | 2005 | — |
| +2 | K123335 | Sunray Fetal Monitor | Sunray Medical Apparatus Co., Ltd. | 2013 | — |
| +1 | K051903 | Fetalgard Lite-Nibp, Model FGL-Nibp | Analogic Corporation | 2005 | — |
| +1 | K050234 | Remote Care | E.Care Solutions, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2013 | 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? (4)
3 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, K043598 (Bionet Co., Ltd., 2005) has gone furthest, with 1 descendant 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/K002503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002503: Fetalgard Lite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002503
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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