510(k) · Cleared
ClearedRecom Battery-Operated Ambulatory Digital Wireless Ecg Monitor, Model 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Recom Managed Systems, Inc. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Jan 28, 2004 as substantially equivalent to K003707 (Cardionet, 2001) and 1 other predicate after a 135-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Jan 28, 2004
- Review
- 135 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K891104 (1989). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK891104 CD Telemetry SystemsMarquette Electronics, Inc. · 1989
- 1 generation backK974149 Ambulatory X-12 Telemetry ModuleMortara Instrument, Inc. · 1998 · Recalled
- This deviceK032882 Recom Battery-Operated Ambulatory Digital Wireless Ecg Monitor…Recom Managed Systems, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891104 | CD Telemetry Systems | Marquette Electronics, Inc. | 1989 | — |
| −1 | K974149 | Ambulatory X-12 Telemetry Module | Mortara Instrument, Inc. | 1998 | 1 |
| 0 (this device) | K032882 | Recom Battery-Operated Ambulatory Digital Wireless Ecg Monitor, Model 100 | Recom Managed Systems, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K003707 | Cardionet Ambulatory Ecg Monitor, Model CN1000ASummary page 1…Wireless ECG Monitor is equivalent to: * CardioNet Ambulatory ECG Monitor, CardioNet, Inc., K003707 * Mortara Ambulatory X- 12 Telemetry Module, Mortara Instruments, Inc.… | 2001 |
| * | K974149 | Ambulatory X-12 Telemetry ModuleSummary page 1…, K003707 * Mortara Ambulatory X- 12 Telemetry Module, Mortara Instruments, Inc. K974149 4. Intended Use: The Recom Model 100 battery-operated Ambulatory, Digital Wirele… | 1998 |
| † | K032103 | Philips Tracemaster Ecg Management System, Models M5100A and M5101A | 2003 |
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 15 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K003707.
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 Recom Model 100 battery-operated Ambulatory, Digital Wireless ECG Monitor System is a true 12 lead ambulatory ECG monitor system capable of recording up to 48 hours of ECG data for the purpose of cardiac monitoring and diagnosis by a medical professional where ambulatory (Holter) monitoring is prescribed by a physician. The system includes recording of ECG data from each of the 12 leads, RF transmission of the recorded data to a PDA and storage. The…
Read the full statement (141 words)
The Recom Model 100 battery-operated Ambulatory, Digital Wireless ECG Monitor System is a true 12 lead ambulatory ECG monitor system capable of recording up to 48 hours of ECG data for the purpose of cardiac monitoring and diagnosis by a medical professional where ambulatory (Holter) monitoring is prescribed by a physician. The system includes recording of ECG data from each of the 12 leads, RF transmission of the recorded data to a PDA and storage.
The stored ECG data is then transferred from the PDA to another device, the Phillips Medical TraceMaster ECG Analysis System for ECG analysis. The Recom Model 100 battery-operated, Ambulatory, Digital, Wireless ECG Monitor System is not intended to sound any physiological alarms.
The Recom Model 100 battery-operated, Ambulatory, Digital Wireless ECG Monitor System is only to be used by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032882 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032882: Recom Battery-Operated Ambulatory Digital Wireless Ecg Monitor, Model 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032882
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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