510(k) · Cleared
ClearedCardioline HD+
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 Aug 27, 2015 as substantially equivalent to K974149 (Mortara Instrument, Inc., 1998) and 1 other predicate after a 203-day review. Its family tree reaches back 3 generations to 2000. 3 later devices descend from it.
- Decided
- Aug 27, 2015
- Review
- 203 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002074 (2000). 6 ancestors in all, the oldest K891104 (1989). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK002074 AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View HesH&C Medical Devices Spa · 2000
- 2 generations backK051534 Cardioline AR 600, AR 1200, AR 2100Et Medical Devices Spa · 2005
- 1 generation backK082124 Carditte MicrotelEt Medical Devices Spa · 2009
- This deviceK150289 Cardioline HD+Cardioline S.P.A · 2015
- Descendant · cites it directly · 0 of its ownK223670 MESI mTablet ECG Diagnostic System, MESI mTablet ECGMesi, Development of Medical Devices, Ltd.; Mesi D.O.O. · 2023
- Descendant · cites it directly · 0 of its ownK220526 HD+12, HD+15Cardioline S.P.A · 2023 · Recalled
- Descendant · cites it directly · 0 of its ownK171019 ScioCardio ECG TransmitterSynergen Technology Labs, LLC · 2018
Most influential descendants
Showing 3 of 3 · See all- K223670MESI mTablet ECG Diagnostic System, MESI mTablet ECGMesi, Development of Medical Devices, Ltd.; Mesi D.O.O. · 2023 · cites it directly0descendants
- K220526HD+12, HD+15Cardioline S.P.A · 2023 · cites it directly0descendants
- K171019ScioCardio ECG TransmitterSynergen Technology Labs, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002074 | AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes | H&C Medical Devices Spa | 2000 | — |
| −2 | K051534 | Cardioline AR 600, AR 1200, AR 2100 | Et Medical Devices Spa | 2005 | — |
| −1 | K082124 | Carditte Microtel | Et Medical Devices Spa | 2009 | — |
| 0 (this device) | K150289 | Cardioline HD+ | Cardioline S.P.A | 2015 | — |
| +1 | K223670 | MESI mTablet ECG Diagnostic System, MESI mTablet ECG | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | 2023 | — |
| +1 | K220526 | HD+12, HD+15 | Cardioline S.P.A | 2023 | 1 |
| +1 | K171019 | ScioCardio ECG Transmitter | Synergen Technology Labs, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 2 | 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? (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 |
|---|---|---|---|
| * | K974149 | Ambulatory X-12 Telemetry ModuleSummary page 4…ufacturer name Applicant Name Predicate Device 510(k) Number Cardioline S.p.A. Cardioline S.p.A. Mortara X-12 K974149 Cardioline S.p.A. Cardioline S.p.A. Et medical devices S.p.A. K082124… | 1998 |
| * | K082124 | Carditte MicrotelSummary page 4…Cardioline S.p.A. Cardioline S.p.A. Mortara X-12 K974149 Cardioline S.p.A. Cardioline S.p.A. Et medical devices S.p.A. K082124 Page 1 of 8 4. DE… | 2009 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K223670 (Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O., 2023) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K974149.
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. 2015, 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?
HD+ is a physiological ECG acquisition module. HD+ transmits wireless, via Bluetooth to a PC or Tablet, the data acquired, without making any analysis or filtering on the data acquired. HD+ acquires 12-lead ECG waveforms meeting the standards for clinical and diagnostic applications (AAMI, ANSI, AHA, ACC) and offers full ECG acquisition. HD+ is designed to acquire and transmit a high quality ECG data allowing the patient to be free to moving (without…
Read the full statement (195 words)
HD+ is a physiological ECG acquisition module. HD+ transmits wireless, via Bluetooth to a PC or Tablet, the data acquired, without making any analysis or filtering on the data acquired.
HD+ acquires 12-lead ECG waveforms meeting the standards for clinical and diagnostic applications (AAMI, ANSI, AHA, ACC) and offers full ECG acquisition.
HD+ is designed to acquire and transmit a high quality ECG data allowing the patient to be free to moving (without cable connected to the processing unit).
The HD+ transmits the acquired physiological signals in real-time to a computer/device where a compatible application is installed.
All data acquired are sent via Bluetooth to a receiver that it can be a PC, tablet or device capable of receiving BT data. The ECG is transmitted verbatim to the receiving system, without LSB or sampling adjustment. It is up to the receiving system/application to perform the necessary processing such as (but not limited to) LSB scaling, signal filtering, Resting ECG analysis etc…
The device HD+ is intended to be used on adult and on all pediatric patients.
The device is intended for use by qualified, trained nurses and physicians operating in hospitals, clinics and medical practices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150289: Cardioline HD+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150289
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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