510(k) · Cleared
ClearedCardio Q50, Cardio Q70
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionet Co., Ltd. · DPS Electrocardiograph
Cleared on Dec 15, 2023 as substantially equivalent to K220535 (Bionet Co., Ltd., 2022) after a 238-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Dec 15, 2023
- Review
- 238 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K895520 (1990). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
- 6 generations backK020708 Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc. · 2002 · Recalled
- 5 generations backK031422 Philips Page Writer Trim Series Cardiograph Including I, II, Iii…Philips Medical Systems · 2003
- 4 generations backK072449 CP100 & 200 12-Lead Resting ElectrocardiographsWelch Allyn, Inc. · 2007
- 3 generations backK102767 Cardio XPBionet Co., Ltd. · 2011
- 2 generations backK113306 Cardio 7Bionet Co., Ltd. · 2012
- 1 generation backK220535 Cardio10Bionet Co., Ltd. · 2022
- This deviceK231160 Cardio Q50, Cardio Q70Bionet Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K895520 | Pagewriter Xli M1700A & Pagewriter XL M1701A | Hewlett-Packard Co. | 1990 | — |
| −6 | K020708 | Philips Pagewriter Touch Cardiograph, Model M5000A Series | Philips Medical Systems, Inc. | 2002 | 2 |
| −5 | K031422 | Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models… | Philips Medical Systems | 2003 | — |
| −4 | K072449 | CP100 & 200 12-Lead Resting Electrocardiographs | Welch Allyn, Inc. | 2007 | — |
| −3 | K102767 | Cardio XP | Bionet Co., Ltd. | 2011 | — |
| −2 | K113306 | Cardio 7 | Bionet Co., Ltd. | 2012 | — |
| −1 | K220535 | Cardio10 | Bionet Co., Ltd. | 2022 | — |
| 0 (this device) | K231160 | Cardio Q50, Cardio Q70 | Bionet Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K220535 | Cardio10Summary page 5…(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow; Primary Predicate device ⚫ 510(k) Number: K220535 ⚫ Applicant: Bionet Co., Ltd. ⚫ Trade/Device Name Cardio10 ⚫ Regulation Number 8… | 2022 |
| † | K160840 | ECG100+, ECG200+ | 2016 |
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 33 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 1 other device also cites its predicate K220535.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Cardio Q50 / Cardio Q70 ECG Analysis System is intended to acquire, analyze, display and record ECG information from adult and pediatric populations. * Bionet Algorithm - 3 years or older / Glasgow Algorithm - 0 years or older The system provides 12-lead ECG and interpretive analysis. The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical…
Read the full statement (171 words)
The Cardio Q50 / Cardio Q70 ECG Analysis System is intended to acquire, analyze, display and record ECG information from adult and pediatric populations.
* Bionet Algorithm - 3 years or older / Glasgow Algorithm - 0 years or older
The system provides 12-lead ECG and interpretive analysis.
The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical professional along with other relevant clinical information.
Sending and receiving ECG data to and from the Hospital Information System is optional.
The Cardio Q50 / Cardio Q70 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.
In addition, the Cardio Q50 / Cardio Q70 is intended for prescription use only to perform spirometry diagnostic tests in adults and pediatric patients aged 5 and older in general practice, specialist and hospital settings. The device is intended to be used what measures patient respiratory parameters including FVC, FEV1/FEV6, SVC, MVV
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231160: Cardio Q50, Cardio Q70.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231160
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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