510(k) · Cleared
ClearedCardio10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionet Co., Ltd. · DPS Electrocardiograph
Cleared on Nov 15, 2022 as substantially equivalent to K113306 (Bionet Co., Ltd., 2012) and 1 other predicate after a 264-day review. Its family tree reaches back 6 generations to 1990. 2 later devices descend from it.
- Decided
- Nov 15, 2022
- Review
- 264 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K895520 (1990). 14 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
- 5 generations backK020708 Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc. · 2002 · Recalled
- 4 generations backK031422 Philips Page Writer Trim Series Cardiograph Including I, II, Iii…Philips Medical Systems · 2003
- 3 generations backK072449 CP100 & 200 12-Lead Resting ElectrocardiographsWelch Allyn, Inc. · 2007
- 2 generations backK102767 Cardio XPBionet Co., Ltd. · 2011
- 1 generation backK113306 Cardio 7Bionet Co., Ltd. · 2012
- This deviceK220535 Cardio10Bionet Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK231160 Cardio Q50, Cardio Q70Bionet Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK231150 Cardio P1Bionet Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K895520 | Pagewriter Xli M1700A & Pagewriter XL M1701A | Hewlett-Packard Co. | 1990 | — |
| −5 | K020708 | Philips Pagewriter Touch Cardiograph, Model M5000A Series | Philips Medical Systems, Inc. | 2002 | 2 |
| −4 | K031422 | Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models… | Philips Medical Systems | 2003 | — |
| −3 | K072449 | CP100 & 200 12-Lead Resting Electrocardiographs | Welch Allyn, Inc. | 2007 | — |
| −2 | K102767 | Cardio XP | Bionet Co., Ltd. | 2011 | — |
| −1 | K113306 | Cardio 7 | Bionet Co., Ltd. | 2012 | — |
| 0 (this device) | K220535 | Cardio10 | Bionet Co., Ltd. | 2022 | — |
| +1 | K231160 | Cardio Q50, Cardio Q70 | Bionet Co., Ltd. | 2023 | — |
| +1 | K231150 | Cardio P1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K113306 | Cardio 7Summary page 5…te Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow; Predicate device ⚫ 510(k) Number: K113306 ⚫ Applicant: Bionet Co., Ltd. ⚫ Trade/Device Name Cardio7 ⚫ Regulation Number 870.2… | 2012 |
| * | K130322 | SPM-300Summary page 5…gulation Name: Electrocardiograph ⚫ Regulation Class: 2 ⚫ Product Code: DPS Reference device ⚫ 510(k) Number: K130322 ⚫ Applicant: Bionet Co., Ltd. ⚫ Trade/Device Name SPM-300 ⚫ Regulation Number 868.1… | 2013 |
What descends from it? (2)
2 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 32 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K231160 (Bionet Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Cardio10 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Pediatric population is defined as patients between the ages from 3 and less than 16 years. Basic systems deliver 12 lead ECG’s, interpretive analysis, and can be upgraded to provide software analysis options such as a high resolution signal averaging of QRS and P wave portions of the…
Read the full statement (187 words)
The Cardio10 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations.
Pediatric population is defined as patients between the ages from 3 and less than 16 years.
Basic systems deliver 12 lead ECG’s, interpretive analysis, and can be upgraded to provide software analysis options such as a high resolution signal averaging of QRS and P wave portions of the electrocardiogram. The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.
Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
The Cardio10 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional’s facility.
Cardio10 is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients, 5 years and older, in general practice, specialty physician, and hospital settings. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, COPD, SVC, MVV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220535: Cardio10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220535
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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