510(k) · Cleared
ClearedRooti Rx ECG Event Recorder, Rooti Link APP Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rooti Labs, Ltd. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Nov 7, 2017 as substantially equivalent to K123658 (Zephyr Technology Corporation, 2013) after a 314-day review. Its family tree reaches back 1 generation to 2013. 1 later device descends from it.
- Decided
- Nov 7, 2017
- Review
- 314 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K123658 (2013). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K213233EZYPRO ECG Recorder (Model: UG02)Sigknow Biomedical Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K123658 | Biomodule 3-M1 | Zephyr Technology Corporation | 2013 | — |
| 0 (this device) | K163694 | Rooti Rx ECG Event Recorder, Rooti Link APP Software | Rooti Labs, Ltd. | 2017 | — |
| +1 | K213233 | EZYPRO ECG Recorder (Model: UG02) | Sigknow Biomedical Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 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 |
|---|---|---|---|
| * | K123658 | Biomodule 3-M1Summary page 4…er Regulation Number: 21 CFR 870.2910 Product Code: DRG Device Class: II 4. Predicate Device Zephyr Technology, BIOMODULE 3-M1, 510(k) number K123658. 5. Intended Use - The intended use of the Rooti Rx System is to allow a patient at home or in the workplace to r… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213233 | EZYPRO ECG Recorder (Model: UG02) | 2022 | 0 |
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?
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
- The intended use of the Rooti Rx System is to allow a patient at home or in the workplace to record single-lead electrocardiography (ECG) data for post-analysis by medical professionals. The Rooti Rx device stores the ECG data, and the recorded data is transmitted to a medical professional’s iOS device via Wi-Fi at a later time.
- The device is not intended to be used on critical care patients. The Rooti Rx System is indicated for use on general care patients and on patients who are 21 years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163694: Rooti Rx ECG Event Recorder, Rooti Link APP Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163694
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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