510(k) · Cleared
ClearedPortable Ecscope 12I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dyansys, Inc. · DPS Electrocardiograph
Cleared on Jan 16, 2008 as substantially equivalent to K072353 (Dyansys Corp, 2007) and 2 other predicates after a 9-day review. Its family tree reaches back 4 generations to 1990. 2 later devices descend from it.
- Decided
- Jan 16, 2008
- Review
- 9 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K895520 (1990). 7 ancestors in all, the oldest K880357 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
- 3 generations backK954980 Pagewriter 200, 200I Cardiograph & Interpretive CardioHewlett-Packard Co. · 1996
- 2 generations backK032200 Elan Digital 12 Channel ElectrocardiographRemco Italia S.P.A. · 2003
- 1 generation backK072353 Portable EcscopeDyansys Corp · 2007
- This deviceK080036 Portable Ecscope 12IDyansys, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK091397 Ecscope 200Dyansys, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK091358 Ecscope 100Dyansys, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K895520 | Pagewriter Xli M1700A & Pagewriter XL M1701A | Hewlett-Packard Co. | 1990 | — |
| −3 | K954980 | Pagewriter 200, 200I Cardiograph & Interpretive Cardio | Hewlett-Packard Co. | 1996 | — |
| −2 | K032200 | Elan Digital 12 Channel Electrocardiograph | Remco Italia S.P.A. | 2003 | — |
| −1 | K072353 | Portable Ecscope | Dyansys Corp | 2007 | — |
| 0 (this device) | K080036 | Portable Ecscope 12I | Dyansys, Inc. | 2008 | — |
| +1 | 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 |
|---|---|---|
| 2009 | 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 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 |
|---|---|---|---|
| * | K072353 | Portable EcscopeSummary page 1…: Class II Trade Name: Portable ECScope 12i Common Name: ECG Monitor Classification Name: Electrocardiograph Predicate Devices: a. K Number: K072353, Model Name: Portable ECScope Manufacturer - DyAnsys, Inc b. K Number: K954980, Model Name: M… | 2007 |
| * | K954980 | Pagewriter 200, 200I Cardiograph & Interpretive CardioSummary page 1…Name: Electrocardiograph Predicate Devices: a. K Number: K072353, Model Name: Portable ECScope Manufacturer - DyAnsys, Inc b. K Number: K954980, Model Name: M 1770A Pagewriter 200 Manufacturer - HEWLETT-PACKARD CO c. K Number: K032200… | 1996 |
| * | K032200 | Elan Digital 12 Channel ElectrocardiographSummary page 1…Manufacturer - DyAnsys, Inc b. K Number: K954980, Model Name: M 1770A Pagewriter 200 Manufacturer - HEWLETT-PACKARD CO c. K Number: K032200 Model Name: ELANO Digital 12 Channel Electrocardiograph Manufacturer - REMCO ITALIA S.P.A Dyansys, Inc ==… | 2003 |
What descends from it? (2)
2 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 18 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K091397 (Dyansys, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K072353.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Portable ECScope 12i hand held, battery operated 12 channel electrocardiograph is intended to be used for the evaluation of the cardiovascular system. Portable ECScope 12i will acquire, record 12 ECG leads simultaneously and display 3 leads in its display unit. Portable ECScope 12i is intended to be used by a licensed health care practitioner or under the direct supervision of a licensed health care practitioner in a hospital or health care environment.…
Read the full statement (111 words)
Portable ECScope 12i hand held, battery operated 12 channel electrocardiograph is intended to be used for the evaluation of the cardiovascular system. Portable ECScope 12i will acquire, record 12 ECG leads simultaneously and display 3 leads in its display unit.
Portable ECScope 12i is intended to be used by a licensed health care practitioner or under the direct supervision of a licensed health care practitioner in a hospital or health care environment. These measurements are not intended for a specific clinical diagnosis. The clinical significance of the ECG tracings must be determined by the physician in conjunction with clinician's knowledge of patient, the results of physical examination and other clinical findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080036 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080036: Portable Ecscope 12I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080036
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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