510(k) · Cleared
ClearedPelex-04 Wireless Electrocardiograph with Software Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pinmed, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Jul 21, 2006 after an 8-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Jul 21, 2006
- Review
- 8 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK061977 Pelex-04 Wireless Electrocardiograph with Software AccessoriesPinmed, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK100813 QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS…Pulse Biomedical, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK142352 CardiacLinxRoss Medical Technology, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061977 | Pelex-04 Wireless Electrocardiograph with Software Accessories | Pinmed, Inc. | 2006 | — |
| +1 | K100813 | QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card Usb | Pulse Biomedical, Inc. | 2010 | — |
| +2 | K142352 | CardiacLinx | Ross Medical Technology, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 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?
The FDA summary names no predicate by number.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100813 | QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card Usb | 2010 | 1 |
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, K100813 (Pulse Biomedical, Inc., 2010) has gone furthest, with 1 descendant 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?
1-12 lead electrocardiograph capable of recording and transmitting standard FCGs for the purpose of cardiac monitoring and diagnosis; the system incorporates recordingz/ transmitting circLitry, a package of firmware and software, and is intended for use h\ a medical protlessional * The ECG can be recorded and transmitted to a local or remote receiving station for consultation wxith a medical professional * T'Ile [CG can be recorded and transmitted to a…
Read the full statement (125 words)
1-12 lead electrocardiograph capable of recording and transmitting standard FCGs for the purpose of cardiac monitoring and diagnosis; the system incorporates recordingz/ transmitting circLitry, a package of firmware and software, and is intended for use h\ a medical protlessional
* The ECG can be recorded and transmitted to a local or remote receiving station for consultation wxith a medical professional
* T'Ile [CG can be recorded and transmitted to a local or remote hand-held de\ ice or a Personal Computer or a printer for viewing and processing
. \llows patients at Jelotc locations to display and transmit their lICG data to medical prIoIessioll• viaa~tcomImlnictlI o device to a i'reote server
Iitcirled for self-testing I\ patients and 1y healthcare professionals at home and in medical seilings
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061977 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061977: Pelex-04 Wireless Electrocardiograph with Software Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061977
Report an extraction error
Are you the manufacturer?
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