510(k) · Cleared
ClearedSafeBeat Rx App
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SafeBeat Rx, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Feb 6, 2026 as substantially equivalent to K170568 (Cardiologs Technologies, 2017) after a 291-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Feb 6, 2026
- Review
- 291 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003621 (2000). No later device cites it as a predicate yet.
- Root · 5 generations backK003621 ST/AR ST and Arrhythmia Software, Model Release D.0Agilent Technologies, Inc. · 2000
- 4 generations backK013717 Brentwood Real Time ST and Arrhythmia Analysis Software LibraryBrentwood Medical Technology Corp. · 2002
- 3 generations backK043380 Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc. · 2005
- 2 generations backK062282 Monebo Automated Ecg Analysis and Interpretation Software Library…Monebo Technologies, Inc. · 2007
- 1 generation backK170568 CardioLogs ECG Analysis PlatformCardiologs Technologies · 2017
- This deviceK251218 SafeBeat Rx AppSafeBeat Rx, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003621 | ST/AR ST and Arrhythmia Software, Model Release D.0 | Agilent Technologies, Inc. | 2000 | — |
| −4 | K013717 | Brentwood Real Time ST and Arrhythmia Analysis Software Library | Brentwood Medical Technology Corp. | 2002 | — |
| −3 | K043380 | Monebo Automatic Arrhythmia Detection Software Library, Version 1 | Monebo Technologies, Inc. | 2005 | — |
| −2 | K062282 | Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0 | Monebo Technologies, Inc. | 2007 | — |
| −1 | K170568 | CardioLogs ECG Analysis Platform | Cardiologs Technologies | 2017 | — |
| 0 (this device) | K251218 | SafeBeat Rx App | SafeBeat Rx, Inc. | 2026 | — |
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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 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 |
|---|---|---|---|
| * | K170568 | CardioLogs ECG Analysis PlatformSummary page 5…21 CFR 870.2340 Product Code DPS) Common/Usual Name: ECG Analysis Program Equivalent Legally Marketed Devices CardioLogs Technologies, CardioLogs ECG Analysis Platform, K170568 Reference Devices AliveCor, Inc., AliveCor QT Service, K212662 Description of the Device The SafeBeat Rx App is a Software as a… | 2017 |
| † | K212662 | AliveCor QT Service | 2022 |
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 26 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- None of the 5 ancestors has a recall.
- 4 other devices also cite its predicate K170568.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The SafeBeat Rx App analyzes ECG data recorded in compatible formats. This ECG signal may originate from a full 12-lead ECG or a reduced lead set ECG. The device provides ECG signal processing and provisional analysis, including interval measurements (QT interval, QTc, ORS duration, heart rate, and RR interval), along with visible display of ORS onset (Q-start), R-peak, and ORS offset (S-end). The SafeBeat Rx App can electronically interface with, and…
Read the full statement (289 words)
The SafeBeat Rx App analyzes ECG data recorded in compatible formats. This ECG signal may originate from a full 12-lead ECG or a reduced lead set ECG. The device provides ECG signal processing and provisional analysis, including interval measurements (QT interval, QTc, ORS duration, heart rate, and RR interval), along with visible display of ORS onset (Q-start), R-peak, and ORS offset (S-end). The SafeBeat Rx App can electronically interface with, and perform analysis of, data transferred from other computer-based ECG systems, such as an ECG management system. The SafeBeat Rx App does not provide real-time ECG display, continuous monitoring, or alarm functions. The device is not for use in life-supporting or sustaining systems or ECG monitor and alarm devices. The SafeBeat Rx App ECG analysis is intended for adult patient populations (18 years and older).
SafeBeat Rx App provisional ECG analysis is not intended to be the sole means of diagnosis. The SafeBea Rx App is not validated for use in lead I alone. The SafeBeat Rx App is intended to be used on an advisory basis only by qualified healthcare personnel to evaluate provisional ECG data. ECG data should be reviewed in conjunction with the patient's clinical history, symptoms, and/or other diagnostic tests, and the professional clinical judgement of the qualified healthcare provider.
The SafeBeat Rx App can be used in a professional healthcare environment such as a hospital , clinic or similarly equipped facility. The SafeBeat Rx App has an optional long term monitoring workflow intended for monitoring and evaluating a patient's home acquired ECG. The software workflow that is intended for use in the professional healthcare environment should not be used in the home environment to adjust QT prolonQinQ medications as is contraindicated for applicable druQs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251218: SafeBeat Rx App.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251218
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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