510(k) · Cleared
ClearedECG100+, ECG200+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardioline S.P.A · DPS Electrocardiograph
Cleared on Aug 12, 2016 as substantially equivalent to K051534 (Et Medical Devices Spa, 2005) and 1 other predicate after a 137-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Aug 12, 2016
- Review
- 137 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933143 (1994). 9 ancestors in all, the oldest K920626 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 3 generations backK062677 Eli 350 ElectrocardiographMortara Instrument, Inc. · 2006
- 2 generations backK082946 Mortara Eli 350 ElectrocardiographMortara Instrument, Inc. · 2008
- 1 generation backK101403 Eli 250 ElectrocardiographMortara Instrument, Inc. · 2010 · Recalled
- This deviceK160840 ECG100+, ECG200+Cardioline S.P.A · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −3 | K062677 | Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2006 | — |
| −2 | K082946 | Mortara Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2008 | — |
| −1 | K101403 | Eli 250 Electrocardiograph | Mortara Instrument, Inc. | 2010 | 1 |
| 0 (this device) | K160840 | ECG100+, ECG200+ | Cardioline S.P.A | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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 |
|---|---|---|---|
| * | K051534 | Cardioline AR 600, AR 1200, AR 2100Summary page 4…urer name Applicant Name Predicate Device 510(k) Number Cardioline S.p.A. Cardioline S.p.A. ET MEDICAL DEVICES SPA K051534 Cardioline S.p.A. Cardioline S.p.A. MORTARA INSTRUMENTS INC. K101403 4. DEVICE DESCRIPTION ECGxxx… | 2005 |
| * | K101403 | Eli 250 ElectrocardiographSummary page 4…rdioline S.p.A. Cardioline S.p.A. ET MEDICAL DEVICES SPA K051534 Cardioline S.p.A. Cardioline S.p.A. MORTARA INSTRUMENTS INC. K101403 4. DEVICE DESCRIPTION ECGxxx(z)(+) is a family of high‐performance, multi‐channel, interpretative resting electrocardiogra… | 2010 |
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 22 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 4 other devices also cite its predicate K051534.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
ECGxxx(z)(+) is a high-performance, multi-channel, interpretative resting electrocardiograph. The ECG signal is acquired with a 10-wires patient cable and is displayed in real time on a LCD screen integrated in the device. The electrocardiograph can analyse and store the ECG traces, send them to an external peripheral via network or via USB, print the 12 lead ECG in automatic or manual mode by means of a thermal printer. ECGxxx(z)(+) is intended for…
Read the full statement (242 words)
ECGxxx(z)(+) is a high-performance, multi-channel, interpretative resting electrocardiograph.
The ECG signal is acquired with a 10-wires patient cable and is displayed in real time on a LCD screen integrated in the device. The electrocardiograph can analyse and store the ECG traces, send them to an external peripheral via network or via USB, print the 12 lead ECG in automatic or manual mode by means of a thermal printer.
ECGxxx(z)(+) is intended for assessment and diagnosis of cardiac functions. In any case the results of analysis performed by the electrocardiograph must be validated by a Physician.
ECGxxx(z)(+) is intended for use in hospitals, in medical clinics and doctor's offices of any size.
- The device is indicated for use to acquire, analyse, display and print electrocardiograms.
- The device is intended to provide the physician with an automatic interpretation of the ECG to be reviewed by a physician.
- The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
- The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
- The device is indicated for use on adult and pediatric populations.
- The device is not intended to be used as a vital signs physiological monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160840 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160840: ECG100+, ECG200+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160840
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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