510(k) · Cleared
ClearedHealthepod
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Card Guard Scientific Survival, Ltd. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Dec 17, 2009 as substantially equivalent to K963725 (Card Guard, Ltd., 1997) and 2 other predicates after a 416-day review. Its family tree reaches back 3 generations to 1997. 15 later devices descend from it.
- Decided
- Dec 17, 2009
- Review
- 416 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K963725 (1997). 6 ancestors in all, the oldest K964836 (1997). 15 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 2 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 1 generation backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- This deviceK083174 HealthepodCard Guard Scientific Survival, Ltd. · 2009
- Descendant · cites it directly · 12 of its ownK093976 Raisin Personal MonitorProteus Biomedical, Inc. · 2010
- Descendant · 2 generations on · 6 of its ownK131009 Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2013
- Descendant · 3 generations on · 4 of its ownK133263 Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK110015 Vitalsens, Aingeal, V-PodIntelesens Limited · 2011
- Descendant · 4 generations on · 3 of its ownK150494 Proteus Digital Health Feedback DeviceProteus Digital Health, Inc. · 2015
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K093976Raisin Personal MonitorProteus Biomedical, Inc. · 2010 · cites it directly12descendants
- K131009Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2013 · 2 generations on6descendants
- K133263Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2014 · 3 generations on4descendants
- K110015Vitalsens, Aingeal, V-PodIntelesens Limited · 2011 · 2 generations on4descendants
- K150494Proteus Digital Health Feedback DeviceProteus Digital Health, Inc. · 2015 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −2 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −1 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| 0 (this device) | K083174 | Healthepod | Card Guard Scientific Survival, Ltd. | 2009 | — |
| +1 | K093976 | Raisin Personal Monitor | Proteus Biomedical, Inc. | 2010 | — |
| +2 | K131009 | Proteus Patch, Ingestible Sensor (Accessory) | Proteus Digital Health, Inc. | 2013 | — |
| +3 | K133263 | Proteus Patch, Proteus Ingestible Sensor (Accessory) | Proteus Digital Health, Inc. | 2014 | — |
| +2 | K110015 | Vitalsens, Aingeal, V-Pod | Intelesens Limited | 2011 | — |
| +4 | K150494 | Proteus Digital Health Feedback Device | Proteus Digital Health, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 DXH? 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 DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified)Summary page 2…?31± The clearance for the HealthePod is sought on the grounds of its claimed susta'l equivalence (SE) to the following predicate devices: 1. Card Guard's CG-2206 K963725 for the one lead feature and similarity in electronic design. 2. Card Guard's PMP 4 SelfCheck EGG K042254 for the over-the-counte… | 1997 |
| * | K042254 | PMP4 Selfcheck EcgSummary page 2…SE) to the following predicate devices: 1. Card Guard's CG-2206 K963725 for the one lead feature and similarity in electronic design. 2. Card Guard's PMP 4 SelfCheck EGG K042254 for the over-the-counter distribution business method when the PMP 4 SelfCheck EGG is set to its one lead configuration. 3. T… | 2005 |
| * | K061800 | Clever TD-1112 Ear/Skin/Surface IR ThermometerSummary page 2…unter distribution business method when the PMP 4 SelfCheck EGG is set to its one lead configuration. 3. TaiDoc Technology Corporation Clever TD-11 112 IRthermometer K061800 5.-CONCLUSIONS The HealthelPod constitutes a safe and reliable device. Its material composition and operation present no adverse… | 2006 |
What descends from it? (15)
See all 152 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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K093976 (Proteus Biomedical, Inc., 2010) has gone furthest, with 12 descendants of its own.
- 4 other devices also cite its predicate K963725.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, 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 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The HealthePod is a medical device designed for self-testing. It comprises the following medical features:
* ECG 1-lead
* Heart rate
* Body temperature
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083174: Healthepod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083174
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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