510(k) · Cleared
ClearedElan Digital 12 Channel Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remco Italia S.P.A. · DPS Electrocardiograph
Cleared on Oct 3, 2003 as substantially equivalent to K954980 (Hewlett-Packard Co., 1996) and 2 other predicates after a 77-day review. Its family tree reaches back 2 generations to 1990. 6 later devices descend from it.
- Decided
- Oct 3, 2003
- Review
- 77 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K895520 (1990). 5 ancestors in all, the oldest K880357 (1988). 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
- 1 generation backK954980 Pagewriter 200, 200I Cardiograph & Interpretive CardioHewlett-Packard Co. · 1996
- This deviceK032200 Elan Digital 12 Channel ElectrocardiographRemco Italia S.P.A. · 2003
- Descendant · cites it directly · 5 of its ownK072353 Portable EcscopeDyansys Corp · 2007
- Descendant · cites it directly · 2 of its ownK080036 Portable Ecscope 12IDyansys, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK082013 Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 2008
- Descendant · 2 generations on · 0 of its ownK091397 Ecscope 200Dyansys, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK091358 Ecscope 100Dyansys, Inc. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K072353Portable EcscopeDyansys Corp · 2007 · cites it directly5descendants
- K080036Portable Ecscope 12IDyansys, Inc. · 2008 · cites it directly2descendants
- K082013Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 2008 · 2 generations on1descendant
- K091397Ecscope 200Dyansys, Inc. · 2009 · 2 generations on0descendants
- K091358Ecscope 100Dyansys, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895520 | Pagewriter Xli M1700A & Pagewriter XL M1701A | Hewlett-Packard Co. | 1990 | — |
| −1 | K954980 | Pagewriter 200, 200I Cardiograph & Interpretive Cardio | Hewlett-Packard Co. | 1996 | — |
| 0 (this device) | K032200 | Elan Digital 12 Channel Electrocardiograph | Remco Italia S.P.A. | 2003 | — |
| +1 | K072353 | Portable Ecscope | Dyansys Corp | 2007 | — |
| +1 | K080036 | Portable Ecscope 12I | Dyansys, Inc. | 2008 | — |
| +2 | K082013 | Clue Medical and Clue Medical Basic | Telovital GmbH Telemedizin | 2008 | — |
| +2 | K091397 | Ecscope 200 | Dyansys, Inc. | 2009 | — |
| +1 | K091358 | Ecscope 100 | Dyansys, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K954980 | Pagewriter 200, 200I Cardiograph & Interpretive CardioSummary page 1…t legally niarketed devices The legally marketed device to which equivalence is being claimed is the M 1770A Pagewriter 200i manufactured by Hewlett-Packard, K954980, Brentwood “Telemed 12 Lead Resting ECG Analysis Library,” KO 10505 and Telemed Oninigraph 6000, K880357 3. Indications f… | 1996 |
| * | K010505 | Telemed 12 Lead Resting Ecg Analysis Library | 2001 |
| * | K880357 | Omnigraph 6000Summary page 1…70A Pagewriter 200i manufactured by Hewlett-Packard, K954980, Brentwood “Telemed 12 Lead Resting ECG Analysis Library,” KO 10505 and Telemed Oninigraph 6000, K880357 3. Indications for Use (intended use) ELAN@ is a digital 12 channel electrocardiograph designed for acquisition and digiti… | 1988 |
What descends from it? (6)
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 13 years and passes through 2 companies; a new generation was cleared every 7.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K072353 (Dyansys Corp, 2007) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K954980.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
ELAN® is a digital 12 channel electrocardiograph designed for acquisition and digitization of conventional diagnostic 12-lead simultaneous ECG waveforms and ECG data and real-time visualization of 1 to 6 leads on its built-in LCD monitor. ELAN® can also record and store in its internal memory up to 100 ECG tests. Each ECG test can be analyzed, printed on the internal thermal printer and/or sent to a PC via serial cable, LAN or modem. ELAN® can perform…
Read the full statement (114 words)
ELAN® is a digital 12 channel electrocardiograph designed for acquisition and digitization of conventional diagnostic 12-lead simultaneous ECG waveforms and ECG data and real-time visualization of 1 to 6 leads on its built-in LCD monitor.
ELAN® can also record and store in its internal memory up to 100 ECG tests. Each ECG test can be analyzed, printed on the internal thermal printer and/or sent to a PC via serial cable, LAN or modem.
ELAN® can perform automatic measurements of ECG waveform and preliminary interpretation of ECG test; measurements and diagnostic statements are offered to the physician on an advisory basis only; the physician is asked to review and validate or change the ECG interpretation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032200: Elan Digital 12 Channel Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032200
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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