510(k) · Cleared
ClearedRemote Care
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E.Care Solutions, Inc. · HGM System, Monitoring, Perinatal
Cleared on Aug 25, 2005 as substantially equivalent to K002503 (Analogic Corp., 2000) after a 205-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Aug 25, 2005
- Review
- 205 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002503 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK002503 Fetalgard LiteAnalogic Corp. · 2000
- This deviceK050234 Remote CareE.Care Solutions, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002503 | Fetalgard Lite | Analogic Corp. | 2000 | — |
| 0 (this device) | K050234 | Remote Care | E.Care Solutions, Inc. | 2005 | — |
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 |
|---|---|---|---|
| * | K002503 | Fetalgard LiteSummary page 1…2. Equivalent devices e.Care Solutions believes the Remote Care is substantially equivalent to Analogic FETALGARD LiteTM by Analogic Corporation, 5 10(k) # K002503. 3. Description of the Device Remote Care is an internet database application and repository for the storage and arc… | 2000 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K002503.
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?
Remote Care is intended to be used only with the Analogic Fetalgard Lite to assist in the transmission and graphical display of maternal abdominal contractions and fetal heart rate. Remote Care receives the strip data from the monitoring system via a modem or the CareStation video phone. This strip data is then transmitted to the Remote Care web site for viewing by the health care provider. Remote Care does not provide real-time capabilities or alerts.…
Read the full statement (140 words)
Remote Care is intended to be used only with the Analogic Fetalgard Lite to assist in the transmission and graphical display of maternal abdominal contractions and fetal heart rate. Remote Care receives the strip data from the monitoring system via a modem or the CareStation video phone. This strip data is then transmitted to the Remote Care web site for viewing by the health care provider.
Remote Care does not provide real-time capabilities or alerts. The device is intended for use to communicate strip data which can be used to aid in assessing the well being of the fetus in the final trimester of pregnancy. Healthcare professionals must apply clinical judgment and experience to assess the data transmitted. The device is not intended as a replacement for professional medical care. It should not be used for patients requiring emergency intervention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050234: Remote Care.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050234
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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