510(k) · Cleared
ClearedPMP4 Medical Web Center
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 Jul 1, 2005 as substantially equivalent to K024365 (Card Guard Scientific Survival, Ltd., 2003) after a 78-day review. Its family tree reaches back 2 generations to 1999. 18 later devices descend from it.
- Decided
- Jul 1, 2005
- Review
- 78 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992164 (1999). 18 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK992164 Telemedicine 2000Card Guard Scientific Survival, Ltd. · 1999
- 1 generation backK024365 TM2005 Personal Medical Phone CenterCard Guard Scientific Survival, Ltd. · 2003
- This deviceK050940 PMP4 Medical Web CenterCard Guard Scientific Survival, Ltd. · 2005
- Descendant · cites it directly · 16 of its ownK131699 Emotion Ecg MobileMega Electronics, Ltd. · 2013
- Descendant · 2 generations on · 8 of its ownK141813 Rhythmstar SystemRhythMedix, LLC · 2014
- Descendant · 2 generations on · 6 of its ownK143032 eMotion Faros ECG MobileMega Electronics, Ltd. · 2015
- Descendant · 3 generations on · 5 of its ownK161431 SimplECGNanowear, Inc. · 2016
- Descendant · 4 generations on · 3 of its ownK201669 SimpleSENSENanowear, Inc. · 2020
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K131699Emotion Ecg MobileMega Electronics, Ltd. · 2013 · cites it directly16descendants
- K141813Rhythmstar SystemRhythMedix, LLC · 2014 · 2 generations on8descendants
- K143032eMotion Faros ECG MobileMega Electronics, Ltd. · 2015 · 2 generations on6descendants
- K161431SimplECGNanowear, Inc. · 2016 · 3 generations on5descendants
- K201669SimpleSENSENanowear, Inc. · 2020 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992164 | Telemedicine 2000 | Card Guard Scientific Survival, Ltd. | 1999 | — |
| −1 | K024365 | TM2005 Personal Medical Phone Center | Card Guard Scientific Survival, Ltd. | 2003 | — |
| 0 (this device) | K050940 | PMP4 Medical Web Center | Card Guard Scientific Survival, Ltd. | 2005 | — |
| +1 | K131699 | Emotion Ecg Mobile | Mega Electronics, Ltd. | 2013 | — |
| +2 | K141813 | Rhythmstar System | RhythMedix, LLC | 2014 | — |
| +2 | K143032 | eMotion Faros ECG Mobile | Mega Electronics, Ltd. | 2015 | — |
| +3 | K161431 | SimplECG | Nanowear, Inc. | 2016 | — |
| +4 | K201669 | SimpleSENSE | Nanowear, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K024365 | TM2005 Personal Medical Phone CenterSummary page 1…medical devices (21 C.F.R. Par. 870.2920 (1992) 3. Substantial Equivalence The basis PMP 4 Medical Web Center is substantially equivalent the TM2005 Receiving Center K024365: it has similar intended use and main principles of operation. The main difference between the systems is that in pMP 4 Center i… | 2003 |
What descends from it? (18)
See all 182 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 6 years and passes through 1 company; a new generation was cleared every 3.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K131699 (Mega Electronics, Ltd., 2013) has gone furthest, with 16 descendants of its own.
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.
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 PMP 4 Medical Web Center is a Software application intended for supporting remote monitoring of Electrocardiographic (ECG), Spirometric, Fetal/Maternal, Blood Pressure, Heart Rate, Blood Glucose, Blood Oxygen Saturation, Body Weight and optionally other patients' vital signs and parameters.
The data is received from transducers/monitors, which are external to the system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050940 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050940: PMP4 Medical Web Center.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050940
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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