510(k) · Cleared
ClearedEcscope 200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dyansys, Inc. · DPS Electrocardiograph
Cleared on Jul 8, 2009 as substantially equivalent to K070614 (Viasys Healthcare GmbH, 2007) and 2 other predicates after a 57-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Jul 8, 2009
- Review
- 57 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K895520 (1990). 10 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 deviceK091397 Ecscope 200Dyansys, 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) | K091397 | Ecscope 200 | Dyansys, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K070614 | CorscreenSummary page 1…cope 200 Common Name: ECG Monitor Classification Name: Electrocardiograph, CFR 870.2340 Product Code: 74 DPS Predicate Devices: a. K Number: K070614 Model Name: CorScreen Manufacturer:Viasys b. K Number: K002074 Model Name: AB Cardiette Dae… | 2007 |
| * | K002074 | AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View HesSummary page 1…2340 Product Code: 74 DPS Predicate Devices: a. K Number: K070614 Model Name: CorScreen Manufacturer:Viasys b. K Number: K002074 Model Name: AB Cardiette Daedalus View Hes Manufacturer: H & C Medical Devices spa c. K Number: K0800… | 2000 |
| * | K080036 | Portable Ecscope 12ISummary page 1…ufacturer:Viasys b. K Number: K002074 Model Name: AB Cardiette Daedalus View Hes Manufacturer: H & C Medical Devices spa c. K Number: K080036 Model Name: Portable ECScope 12i Manufacturer: DyAnsys, Inc L K091397 P%… | 2008 |
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 10 ancestors has a recall.
- 1 other device also cites its predicate K070614.
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 200 portable, battery operated 12 channel electrocardiographs is intended to be used for the diagnosis of cardiovascular system complications. ECScope 200 will acquire and record 12 ECG leads simultaneously. The interpretation software is intended to support the physician in evaluating the ECG in terms of morphology and rhythm. Interpretation results must be overviewed and approved by trained physicians. Interpretation just represents partial…
Read the full statement (129 words)
ECScope 200 portable, battery operated 12 channel electrocardiographs is intended to be used for the diagnosis of cardiovascular system complications. ECScope 200 will acquire and record 12 ECG leads simultaneously.
The interpretation software is intended to support the physician in evaluating the ECG in terms of morphology and rhythm.
Interpretation results must be overviewed and approved by trained physicians. Interpretation just represents partial qualitative and quantitative information of the general patient cardiovascular conditions. No therapy or drugs can be administered based solely on the interpretation statements.
The clinical significance of the ECG tracings must be determined by the physician in conjunction with clinician's knowledge of the patient, the results of physical examination and other clinical findings.
The equipments are intended to be used by trained medical personnel or physicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091397 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091397: Ecscope 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091397
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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