510(k) · Cleared
Recalled · Class II · 2026HD+12, HD+15
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardioline S.P.A · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on May 15, 2023 as substantially equivalent to K150289 (Cardioline S.P.A, 2015) after a 445-day review. Its family tree reaches back 4 generations to 2000. It has been recalled once.
- Decided
- May 15, 2023
- Review
- 445 days
- Class
- Class II
- Product code
- DRG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002074 (2000). 7 ancestors in all, the oldest K891104 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK002074 AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View HesH&C Medical Devices Spa · 2000
- 3 generations backK051534 Cardioline AR 600, AR 1200, AR 2100Et Medical Devices Spa · 2005
- 2 generations backK082124 Carditte MicrotelEt Medical Devices Spa · 2009
- 1 generation backK150289 Cardioline HD+Cardioline S.P.A · 2015
- This deviceK220526 HD+12, HD+15Cardioline S.P.A · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002074 | AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes | H&C Medical Devices Spa | 2000 | — |
| −3 | K051534 | Cardioline AR 600, AR 1200, AR 2100 | Et Medical Devices Spa | 2005 | — |
| −2 | K082124 | Carditte Microtel | Et Medical Devices Spa | 2009 | — |
| −1 | K150289 | Cardioline HD+ | Cardioline S.P.A | 2015 | — |
| 0 (this device) | K220526 | HD+12, HD+15 | Cardioline S.P.A | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K150289 | Cardioline HD+Summary page 5…ufacturer name Applicant Name Predicate Device 510(k) Number Cardioline S.p.A. Cardioline S.p.A. HD+ K150289 4. DEVICE DESCRIPTION HD+12 and HD+15 are the new revisions of Cardioline’s HD+ wireless acquisition module. The HD+ is… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 20, 2026 | Class II | Z-3013-2026 | Software design | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 2 other devices also cite its predicate K150289.
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. 2023, 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 function of the device is the acquisition and transmission of the ECG signal in order to support diagnosis of the patient’s conditions. HD+ is a wireless or USB (with appropriate option) ECG acquisition device, to be used primarily as common front-end for standard PC/tablet platforms (Windows/MAC OS/others), for resting ECG applications. The device implements wireless communication via Bluetooth wireless technology or wired with USB communication.…
Read the full statement (305 words)
The function of the device is the acquisition and transmission of the ECG signal in order to support diagnosis of the patient’s conditions.
HD+ is a wireless or USB (with appropriate option) ECG acquisition device, to be used primarily as common front-end for standard PC/tablet platforms (Windows/MAC OS/others), for resting ECG applications.
The device implements wireless communication via Bluetooth wireless technology or wired with USB communication. With both connection modes, HD+ sends the data to the receiver device without performing any analysis or filtering.
HD+ is not intended for monitoring or analysis of the cardiac function or to diagnose the patient’s health condition. Display, print and analysis applications on the receiver device are separate products. HD+ is not able to permanently store the acquired data, therefore it does not work unless a connection has been established with a receiver application. Furthermore, HD+ does not collect any of the patient’s sensitive data (patient’s name, age, previous health conditions etc.).
HD+ detects the QRS complexes and transmit the results to the receiving device. The QRS detection function is intended for patients aged 12 years or older.
*HD+ is indicated for the acquisition of ECG signals with the patient in resting conditions, for example for diagnostic ECG’s and rhythm strips
*HD+ is suitable for working at high altitudes, with restrictions.
*HD+ is intended for use on patients, with no limits of age or gender, except for the HR detector function which is intended for patients 12 years or older
*HD+ is intended for use in medical facilities (hospitals, clinics), at home or emergency settings (ambulances).
*HD+ is intended for use by a physician, nurse or other healthcare professional (e.g., ECG technician) who acts following orders by a physician or authorized nurse, including when operated in home environments
*HD+ is not intended for real-time monitoring of vital physiological parameters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220526: HD+12, HD+15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220526
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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