510(k) · Cleared
ClearedCardioTag™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiosense, Inc. · DXR Ballistocardiograph
Cleared on Jul 22, 2025 as substantially equivalent to K081603 (Heartforce Medical, Inc., 2009) and 1 other predicate after a 246-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Jul 22, 2025
- Review
- 246 days
- Class
- Class II
- Product code
- DXR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K853124 (1985). 4 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 | K853124 | Novametrix Pulse Oximeter, Model 500 | Novametrix Medical Systems, Inc. | 1985 | — |
| −1 | K023238 | Mcpulse | Meridian Co., Ltd. | 2003 | — |
| 0 (this device) | K243566 | CardioTag™ | Cardiosense, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2009 | 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 DXR? 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? (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 |
|---|---|---|---|
| * | K081603 | Digital Ballistocardiograph, Model DGB 300Summary page 5…21 CFR 870.2320) Regulatory Class: 11 Product Code: DXR (primary); DRG, DPS, MWI I1II. PREDICATE DEVICE Primary: HeartForce Medical, dBG Digital Ballistocardiograph, K081603 Secondary: Meridian, McPulse Photoelectric Plethysmograph, K023238 IV. DEVICE DESCRIPTION The CardioTag device consists of a re… | 2009 |
| * | K023238 | McpulseSummary page 5…; DRG, DPS, MWI I1II. PREDICATE DEVICE Primary: HeartForce Medical, dBG Digital Ballistocardiograph, K081603 Secondary: Meridian, McPulse Photoelectric Plethysmograph, K023238 IV. DEVICE DESCRIPTION The CardioTag device consists of a rechargeable wearable that is responsible for collecting raw cardiac… | 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 40 years and passes through 3 companies; a new generation was cleared every 22.4 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K081603.
How does its category compare?
All DXR devicesDXR Ballistocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DXR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXR
Too few DXR 510(k)s in any year since 2007 to give a median.
Recalls per year · DXR
No recall names DXR since 2007.
Adverse event reports per year · DXR
No MAUDE report names DXR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CardioTag device is a tool that can be used to record, display and transfer vibrational waveforms produced by the heart contractions and transmitted to the chest as well as single-channel electrocardiogram (ECG) rhythms and heart rate. It also measures pulse waveform and pulse rate by photoplethysmograph (PPG). The CardioTag may be used as a tool to measure the timing of the aortic valve opening and closing in the cardiac cycle. The CardioTag is intended for spot-checking of adult patients in clinics or at home under the care of a physician. The data from the CardioTag is intended for use by healthcare professionals as an aid to diagnosis and treatment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243566: CardioTag™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243566
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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