510(k) · Cleared
ClearedBiomodule 3-M1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zephyr Technology Corporation · DRX Electrode, Electrocardiograph
Cleared on Apr 24, 2013 after a 147-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 4 later devices descend from it.
- Decided
- Apr 24, 2013
- Review
- 147 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 1
4 later devices descend from it, 3 citing it directly.
- This deviceK123658 Biomodule 3-M1Zephyr Technology Corporation · 2013
- Descendant · cites it directly · 1 of its ownK181165 Philips wearable biosensor-G5 SolutionConnected Sensing- A Division of Philips Medical Systems · 2019
- Descendant · cites it directly · 1 of its ownK163694 Rooti Rx ECG Event Recorder, Rooti Link APP SoftwareRooti Labs, Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK213233 EZYPRO ECG Recorder (Model: UG02)Sigknow Biomedical Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK192875 Philips Biosensor BX100Philips Medical Systems · 2020
Most influential descendants
Showing 4 of 4 · See all- K181165Philips wearable biosensor-G5 SolutionConnected Sensing- A Division of Philips Medical Systems · 2019 · cites it directly1descendant
- K163694Rooti Rx ECG Event Recorder, Rooti Link APP SoftwareRooti Labs, Ltd. · 2017 · cites it directly1descendant
- K213233EZYPRO ECG Recorder (Model: UG02)Sigknow Biomedical Co., Ltd. · 2022 · 2 generations on0descendants
- K192875Philips Biosensor BX100Philips Medical Systems · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K123658 | Biomodule 3-M1 | Zephyr Technology Corporation | 2013 | — |
| +1 | K181165 | Philips wearable biosensor-G5 Solution | Connected Sensing- A Division of Philips Medical Systems | 2019 | — |
| +1 | K163694 | Rooti Rx ECG Event Recorder, Rooti Link APP Software | Rooti Labs, Ltd. | 2017 | — |
| +2 | K213233 | EZYPRO ECG Recorder (Model: UG02) | Sigknow Biomedical Co., Ltd. | 2022 | — |
| +1 | K192875 | Philips Biosensor BX100 | Philips Medical Systems | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 DRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K130415 | FDA’s K130415 is High Metabolite Qualicheck Our reading of the summary gave K130415, FDA’s number for High Metabolite Qualicheck (Radiometer Medical Aps). Its FDA name has none of the distinctive words the summary uses for the device it names, “Zephyr Technology BioHarness 3.0”. Kept off the family tree. Summary page 1…fieitioh Class 11 *Establishment registration No. # 23383 6 Predicate Device* Zephyr Technology,.RioHarness 3.), K1 130415, transujiits physiological. aai a complex array of packet data. Trademark No… | 2013 |
What descends from it? (4)
3 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?
- Of its descendants, K181165 (Connected Sensing- A Division of Philips Medical Systems, 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DRX devicesDRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DRX
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DRX
78in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRX
6in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRX
250in 2025
MAUDE reports naming product code DRX, 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 | 147 | 0 | 47 |
| 2008 | 3 | 17 | 0 | 15 |
| 2009 | 7 | 89 | 0 | 36 |
| 2010 | 5 | 78 | 4 | 48 |
| 2011 | 0 | — | 0 | 80 |
| 2012 | 0 | — | 0 | 41 |
| 2013 | 1 | — | 0 | 70 |
| 2014 | 1 | — | 0 | 27 |
| 2015 | 0 | — | 1 | 58 |
| 2016 | 0 | — | 0 | 37 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 0 | — | 0 | 43 |
| 2019 | 0 | — | 0 | 50 |
| 2020 | 0 | — | 5 | 53 |
| 2021 | 0 | — | 1 | 55 |
| 2022 | 0 | — | 6 | 61 |
| 2023 | 0 | — | 0 | 113 |
| 2024 | 0 | — | 0 | 61 |
| 2025 | 0 | — | 0 | 250 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BioModule 3-MI is a physiological monitoring telemetry device intended for monitoring ambulatory patients in alternate care settings. The device consists of adhesive electrodes and an electronics module. The device stores and transmits vital sign data including ECG, heart rate, respiration rate, body orientation and activity. The BioModule 3-MI provides a facility to detect and transmit single lead ECG signals to be received by qualified instruments.…
Read the full statement (118 words)
The BioModule 3-MI is a physiological monitoring telemetry device intended for monitoring ambulatory patients in alternate care settings. The device consists of adhesive electrodes and an electronics module. The device stores and transmits vital sign data including ECG, heart rate, respiration rate, body orientation and activity. The BioModule 3-MI provides a facility to detect and transmit single lead ECG signals to be received by qualified instruments.
The BioModule 3-MI collects and transmits measurements captured in alternate care settings as prescribed by the health care professional. Breathing rate values are accurately transmitted only during sedentary periods.
The BioModule 3-MI is indicated for use as a general patient monitor to provide physiological information as part of general ward monitoring system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123658: Biomodule 3-M1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123658
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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