510(k) · Cleared
ClearedThe Portable Ansiscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dyansys, Inc. · DPS Electrocardiograph
Cleared on Aug 31, 2007 as substantially equivalent to K972991 (Qmed, Inc., 1998) and 3 other predicates after a 126-day review. Its family tree reaches back 3 generations to 1995. 7 later devices descend from it.
- Decided
- Aug 31, 2007
- Review
- 126 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K950779 (1995). 9 ancestors in all, the oldest K820885 (1982). 7 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK950779 Heart Rate Variability Software OptionSpacelabs, Inc. · 1995
- 2 generations backK972991 Monitor One NDXQmed, Inc. · 1998
- 1 generation backK991831 BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc. · 1999
- This deviceK071168 The Portable AnsiscopeDyansys, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK123130 Answatch Wrist Monitor Model TS-0411Taiwan Scientific Corporation · 2013
- Descendant · cites it directly · 1 of its ownK082709 Vicor PD2I Analyzer, Version 2.1Vicor Technologies, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK241217 CloudHRV™ System (100-01-001)Inmedix, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK213699 CareTaker Monitor AppCaretaker Medical, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK201914 HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K123130Answatch Wrist Monitor Model TS-0411Taiwan Scientific Corporation · 2013 · cites it directly2descendants
- K082709Vicor PD2I Analyzer, Version 2.1Vicor Technologies, Inc. · 2008 · cites it directly1descendant
- K241217CloudHRV™ System (100-01-001)Inmedix, Inc. · 2025 · cites it directly0descendants
- K213699CareTaker Monitor AppCaretaker Medical, LLC · 2022 · 2 generations on0descendants
- K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950779 | Heart Rate Variability Software Option | Spacelabs, Inc. | 1995 | — |
| −2 | K972991 | Monitor One NDX | Qmed, Inc. | 1998 | — |
| −1 | K991831 | BMT Anscore Health Management System, Model 1.1 | Boston Medical Technologies, Inc. | 1999 | — |
| 0 (this device) | K071168 | The Portable Ansiscope | Dyansys, Inc. | 2007 | — |
| +1 | K123130 | Answatch Wrist Monitor Model TS-0411 | Taiwan Scientific Corporation | 2013 | — |
| +1 | K082709 | Vicor PD2I Analyzer, Version 2.1 | Vicor Technologies, Inc. | 2008 | — |
| +1 | K241217 | CloudHRV™ System (100-01-001) | Inmedix, Inc. | 2025 | — |
| +2 | K213699 | CareTaker Monitor App | Caretaker Medical, LLC | 2022 | — |
| +2 | K201914 | HRVWatch-Mini Wrist Monitor | Taiwan Scientific Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | K972991 | Monitor One NDXSummary page 1…The Portable ANSiscope TM Common Name: ECG Monitor Classification Name: Electrocardiograph Predicate Devices: The Qmed monitor one nDx K972991 The D.E.Hokanson, Inc. ANS2000 K973426 The Anscore System K991831 The MAC 500 ECG Analy… | 1998 |
| * | K973426 | Ans 2000 Ecg Monitor and Respiration PacerSummary page 1…Monitor Classification Name: Electrocardiograph Predicate Devices: The Qmed monitor one nDx K972991 The D.E.Hokanson, Inc. ANS2000 K973426 The Anscore System K991831 The MAC 500 ECG Analysis System K991735 Device Description:… | 1998 |
| * | K991831 | BMT Anscore Health Management System, Model 1.1Summary page 1…dicate Devices: The Qmed monitor one nDx K972991 The D.E.Hokanson, Inc. ANS2000 K973426 The Anscore System K991831 The MAC 500 ECG Analysis System K991735 Device Description: The Portable ANSiscopeTM is a device used for measurin… | 1999 |
| * | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac 8…Summary page 1…K972991 The D.E.Hokanson, Inc. ANS2000 K973426 The Anscore System K991831 The MAC 500 ECG Analysis System K991735 Device Description: The Portable ANSiscopeTM is a device used for measuring heart rate variability (HRV). The device is designed… | 1999 |
What descends from it? (7)
4 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 12 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K123130 (Taiwan Scientific Corporation, 2013) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K972991.
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 DyAnsys, Inc. ANSiscopeTM ECG Monitoring System and accessories, is intended to acquire, analyze, display and record electrocardiographic information and to measure-heart rate variability. These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071168 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071168: The Portable Ansiscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071168
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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