510(k) · Cleared
ClearedEcscope 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dyansys, Inc. · DPS Electrocardiograph
Cleared on May 28, 2009 as substantially equivalent to K072353 (Dyansys Corp, 2007) and 2 other predicates after a 20-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- May 28, 2009
- Review
- 20 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K895520 (1990). 8 ancestors in all, the oldest K880357 (1988). No later device cites it as a predicate yet.
- Root · 5 generations backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
- 4 generations backK954980 Pagewriter 200, 200I Cardiograph & Interpretive CardioHewlett-Packard Co. · 1996
- 3 generations backK032200 Elan Digital 12 Channel ElectrocardiographRemco Italia S.P.A. · 2003
- 2 generations backK072353 Portable EcscopeDyansys Corp · 2007
- 1 generation backK080036 Portable Ecscope 12IDyansys, Inc. · 2008
- This deviceK091358 Ecscope 100Dyansys, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K895520 | Pagewriter Xli M1700A & Pagewriter XL M1701A | Hewlett-Packard Co. | 1990 | — |
| −4 | K954980 | Pagewriter 200, 200I Cardiograph & Interpretive Cardio | Hewlett-Packard Co. | 1996 | — |
| −3 | K032200 | Elan Digital 12 Channel Electrocardiograph | Remco Italia S.P.A. | 2003 | — |
| −2 | K072353 | Portable Ecscope | Dyansys Corp | 2007 | — |
| −1 | K080036 | Portable Ecscope 12I | Dyansys, Inc. | 2008 | — |
| 0 (this device) | 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 |
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…ECScope 100 Common Name: ECG Monitor Classification Name: Electrocardiograph, CFR 870.2340 Product Code: 74 DPS Predicate Devices: a. K Number: K0723 53, Model Name: Portable ECScope Manufacturer - DyAnsys, Inc b. K Number: K080036, Model Name: P… | 2007 |
| * | K080036 | Portable Ecscope 12ISummary page 1…t Code: 74 DPS Predicate Devices: a. K Number: K0723 53, Model Name: Portable ECScope Manufacturer - DyAnsys, Inc b. K Number: K080036, Model Name: Portable ECSCOPE 12i Manufacturer - DyAnsys, Inc c. K Number: K032200 Model Name:… | 2008 |
| * | K032200 | Elan Digital 12 Channel ElectrocardiographSummary page 1…ope Manufacturer - DyAnsys, Inc b. K Number: K080036, Model Name: Portable ECSCOPE 12i Manufacturer - DyAnsys, Inc c. K Number: K032200 Model Name: ELANO Digital 12 Channel Electrocardiograph Manufacturer - REMCO ITALIA S.P.A Dyansys, Inc… | 2003 |
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 19 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 8 ancestors has a recall.
- 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. 2009, 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?
ECScope 100 hand held, battery operated 12 channel electrocardiograph is intended to be used for the diagnosis of cardiovascular system complications. ECScope 100 will acquire and record 12 ECG leads simultaneously.
ECScope 100 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/K091358 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091358: Ecscope 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091358
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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