510(k) · Cleared
ClearedHyperq Acs-100 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bsp-Biiological Signal Processing, Ltd. · DPS Electrocardiograph
Cleared on Oct 28, 2014 as substantially equivalent to K090212 (Ge Medical Syst. Information Technologies, 2009) and 1 other predicate after a 298-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Oct 28, 2014
- Review
- 298 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K903644 (1991). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK903644 Series 1500 12-Lead Analysis OptionMarquette Electronics, Inc. · 1991
- 6 generations backK973403 Cardiosmart STMarquette Medical Systems, Inc. · 1998
- 5 generations backK991014 Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn · 1999
- 4 generations backK023380 T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002
- 3 generations backK031561 Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003
- 2 generations backK081437 Mac 1600 Ecg Analysis SystemGe Medical Systems Information Technologies · 2008
- 1 generation backK090212 Mac 800 Resting Ecg Analysis SystemGe Medical Syst. Information Technologies · 2009 · Recalled
- This deviceK140020 Hyperq Acs-100 SystemBsp-Biiological Signal Processing, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K903644 | Series 1500 12-Lead Analysis Option | Marquette Electronics, Inc. | 1991 | — |
| −6 | K973403 | Cardiosmart ST | Marquette Medical Systems, Inc. | 1998 | — |
| −5 | K991014 | Case 8000 Exercise Testing System | General Electric Medical Systems Information Techn | 1999 | — |
| −4 | K023380 | T-Wave Altermans (Twa) Algorithm Option | General Electric Medical Systems Information Techn | 2002 | — |
| −3 | K031561 | Cardiosoft/Case Cardiac Testing System | Ge Medical Systems Information Technologies | 2003 | — |
| −2 | K081437 | Mac 1600 Ecg Analysis System | Ge Medical Systems Information Technologies | 2008 | — |
| −1 | K090212 | Mac 800 Resting Ecg Analysis System | Ge Medical Syst. Information Technologies | 2009 | 1 |
| 0 (this device) | K140020 | Hyperq Acs-100 System | Bsp-Biiological Signal Processing, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K090212 | Mac 800 Resting Ecg Analysis SystemSummary page 4…devices. Manufacturer Device 510(k) No. GE Medical Systems MAC 800 Resting ECG Analysis System K090212 Information Technologies BSP Ltd. HyperQ™ AD-100 System K102579… | 2009 |
| * | K102579 | Hyperq AD-100 SystemSummary page 4…Systems MAC 800 Resting ECG Analysis System K090212 Information Technologies BSP Ltd. HyperQ™ AD-100 System K102579 K140020 Page 1 of 4 Device Description: The H… | 2010 |
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 23 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 2 other devices also cite its predicate K090212.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 BSP HyperQ™ Rest System is intended to be used during rest ECG tests, using the analysis of high frequency components present within the central portion of the QRS complex (HF-QRS). The device outputs a reduced amplitude zone (RAZ) value for the physician to interpret (based on reported clinical study results). The device is indicated for use in the ECG interpretation of patients with acute chest pain presenting to the Emergency Department, aged 18…
Read the full statement (117 words)
The BSP HyperQ™ Rest System is intended to be used during rest ECG tests, using the analysis of high frequency components present within the central portion of the QRS complex (HF-QRS). The device outputs a reduced amplitude zone (RAZ) value for the physician to interpret (based on reported clinical study results). The device is indicated for use in the ECG interpretation of patients with acute chest pain presenting to the Emergency Department, aged 18 years and above, as an additional adjunctive aid during initial patient presentation. The significance of the HF-QRS changes and interpretation of the HyperQ™ Rest analysis must be determined by a physician, based on the reported clinical study results presented in the device labeling.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140020: Hyperq Acs-100 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140020
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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