510(k) · Cleared
ClearedFrontier X Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fourth Frontier Technologies Pvt, Ltd. · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Nov 8, 2024 as substantially equivalent to K201644 (Qardio, Inc., 2021) and 1 other predicate after a 231-day review. Its family tree reaches back 2 generations to 2012.
- Decided
- Nov 8, 2024
- Review
- 231 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K121319 (2012). 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 | K121319 | Zio Patch | iRhythm Technologies, Inc. | 2012 | — |
| −1 | K201644 | QardioCore | Qardio, Inc. | 2021 | — |
| 0 (this device) | K240794 | Frontier X Plus | Fourth Frontier Technologies Pvt, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 MLO? 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 MLO device
- #1 K261580 ZBPro Diagnostic (Version 2.0)score 13.8 · 7 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 |
|---|---|---|---|
| * | K201644 | QardioCoreSummary page 5…rder Classification: 21 CFR§870.2800, Medical Magnetic Tape Recorder, Class II Product Code: MLO Subsequent Product Code(s): DXH , DPS PREDICATE DEVICE(S) [807.92(a)(3)] K201644 – QardioCore ECG Monitor (primary predicate device) Product code: DSH K182396 – AliveCor Heart Monitor (predicate device, curren… | 2021 |
| * | K182396 | KardiaMobile, KardiaStationSummary page 5…Product Code: MLO Subsequent Product Code(s): DXH , DPS PREDICATE DEVICE(S) [807.92(a)(3)] K201644 – QardioCore ECG Monitor (primary predicate device) Product code: DSH K182396 – AliveCor Heart Monitor (predicate device, currently marketed as “KardiaMobile”) Product code: DXH, DPS… | 2019 |
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 12 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All MLO devicesMLO Electrocardiograph, Ambulatory, With Analysis Algorithm: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MLO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLO
238in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLO
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLO
4in 2025
MAUDE reports naming product code MLO, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 3 | 238 | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 2 | 2 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Frontier X Plus device is an ambulatory monitoring device intended to record, store, and transfer single-channel (ECG) rhythms for monitoring and evaluation. The Frontier X Plus system also displays ECG waveforms and ECG rhythm analysis; detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, inconclusive and unreadable rhythm. The Frontier X Plus is intended for use by healthcare professionals, patients with…
Read the full statement (133 words)
The Frontier X Plus device is an ambulatory monitoring device intended to record, store, and transfer single-channel (ECG) rhythms for monitoring and evaluation. The Frontier X Plus system also displays ECG waveforms and ECG rhythm analysis; detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, inconclusive and unreadable rhythm. The Frontier X Plus is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms requiring cardiac monitoring. The device has not been tested for pediatric use. The Frontier X Plus is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240794 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240794: Frontier X Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240794
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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