510(k) · Cleared
ClearedPortable Ecscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dyansys Corp · DPS Electrocardiograph
Cleared on Aug 30, 2007 as substantially equivalent to K954980 (Hewlett-Packard Co., 1996) and 1 other predicate after an 8-day review. Its family tree reaches back 3 generations to 1990. 5 later devices descend from it.
- Decided
- Aug 30, 2007
- Review
- 8 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K895520 (1990). 6 ancestors in all, the oldest K880357 (1988). 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
- 2 generations backK954980 Pagewriter 200, 200I Cardiograph & Interpretive CardioHewlett-Packard Co. · 1996
- 1 generation backK032200 Elan Digital 12 Channel ElectrocardiographRemco Italia S.P.A. · 2003
- This deviceK072353 Portable EcscopeDyansys Corp · 2007
- Descendant · cites it directly · 2 of its ownK080036 Portable Ecscope 12IDyansys, Inc. · 2008
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 0 of its ownK083630 Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 2009
Most influential descendants
Showing 5 of 5 · See all- K080036Portable Ecscope 12IDyansys, Inc. · 2008 · cites it directly2descendants
- K082013Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 2008 · cites it directly1descendant
- K091397Ecscope 200Dyansys, Inc. · 2009 · 2 generations on0descendants
- K091358Ecscope 100Dyansys, Inc. · 2009 · cites it directly0descendants
- K083630Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895520 | Pagewriter Xli M1700A & Pagewriter XL M1701A | Hewlett-Packard Co. | 1990 | — |
| −2 | K954980 | Pagewriter 200, 200I Cardiograph & Interpretive Cardio | Hewlett-Packard Co. | 1996 | — |
| −1 | K032200 | Elan Digital 12 Channel Electrocardiograph | Remco Italia S.P.A. | 2003 | — |
| 0 (this device) | K072353 | Portable Ecscope | Dyansys Corp | 2007 | — |
| +1 | K080036 | Portable Ecscope 12I | Dyansys, Inc. | 2008 | — |
| +1 | 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 | — |
| +2 | K083630 | Clue Medical and Clue Medical Basic | Telovital GmbH Telemedizin | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K954980 | Pagewriter 200, 200I Cardiograph & Interpretive CardioSummary page 1…tion: Class II Trade Name: Portable ECScope Common Name: ECG Monitor Classification Name: Electrocardiograph Predicate Devices: a. K Number: K954980, Model Name: M 1770A Pagewriter 200 Manufacturer - HEWLETT-PACKARD CO b. K Number: K032200 Mo… | 1996 |
| * | K032200 | Elan Digital 12 Channel ElectrocardiographSummary page 1…rocardiograph Predicate Devices: a. K Number: K954980, Model Name: M 1770A Pagewriter 200 Manufacturer - HEWLETT-PACKARD CO b. K Number: K032200 Model Name: ELANO Digital 12 Channel Electrocardiograph Manufacturer - REMCO ITALIA S.P.A Device Description… | 2003 |
What descends from it? (5)
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 17 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K080036 (Dyansys, Inc., 2008) has gone furthest, with 2 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. 2007, 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?
The Portable ECScope handheld, battery operated Multi channel electrocardiograph is intended to be used for evaluation of the cardiovascular system. The Portable ECScope will acquire, display and record Multi channel ECG signals.
The Portable ECScope 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 specific clinical diagnosis. The clinical significance must be determined by a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072353 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072353: Portable Ecscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072353
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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