510(k) · Cleared
ClearedPE 501 PC-Ecg Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nhe Corp. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Jan 13, 2000 as substantially equivalent to K981394 (Braemar Corp., 1998) and 1 other predicate after a 164-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Jan 13, 2000
- Review
- 164 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K923930 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923930 | Electrocardiograph Transmitter | Tz Medical, Inc. | 1992 | — |
| −1 | K981394 | Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720 | Braemar Corp. | 1998 | — |
| 0 (this device) | K992584 | PE 501 PC-Ecg Monitor | Nhe Corp. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 MWJ? 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 MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K981394 | Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720Summary page 1…y disk, direct machine to machine or E-mail. Substantially Equivalent (SE) to: Technological ER 700 Series Ambulatory ECG Event Monitor by Braemar Corp., MN, 510(k)# K981394 PC-ECG, by L.P.I. — International Products Inc., the basic model, PC-ECG, of a PC-ECG series of family with no interpretation fu… | 1998 |
| * | K963578 | PC Based Electrocardiograph System (PC-Ecg)Summary page 1…., MN, 510(k)# K981394 PC-ECG, by L.P.I. — International Products Inc., the basic model, PC-ECG, of a PC-ECG series of family with no interpretation functions. 510(k)# K963578 characteristics: All three devices compared use similar technologies to acquire patient’s ECG signals, amplify the signals, per… | 1997 |
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K981394.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, 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 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
The PE 501 PC-ECG is indicated for acquiring and displaying 2 channel ECG signals through a personal computer and transferring the recorded ECG signals to a remote computer.
It is designed for stationary use and is not for ambulatory use. It is intended for use primarily in out-patient clinics. The PE 501 PC-ECG device should be operated by a licensed healthcare practitioner.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992584 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992584: PE 501 PC-Ecg Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992584
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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