510(k) · Cleared
ClearedCP100 & 200 12-Lead Resting Electrocardiographs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · DPS Electrocardiograph
Cleared on Nov 29, 2007 as substantially equivalent to K001265 (Welch Allyn, Inc., 2000) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 1990. 7 later devices descend from it.
- Decided
- Nov 29, 2007
- Review
- 90 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K895520 (1990). 4 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
- 2 generations backK020708 Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc. · 2002 · Recalled
- 1 generation backK031422 Philips Page Writer Trim Series Cardiograph Including I, II, Iii…Philips Medical Systems · 2003
- This deviceK072449 CP100 & 200 12-Lead Resting ElectrocardiographsWelch Allyn, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK102767 Cardio XPBionet Co., Ltd. · 2011
- Descendant · 2 generations on · 3 of its ownK113306 Cardio 7Bionet Co., Ltd. · 2012
- Descendant · 3 generations on · 2 of its ownK220535 Cardio10Bionet Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK131573 CP150 ElectrocardiographWelch Allyn, Inc. · 2013
- Descendant · 4 generations on · 0 of its ownK231160 Cardio Q50, Cardio Q70Bionet Co., Ltd. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K102767Cardio XPBionet Co., Ltd. · 2011 · cites it directly4descendants
- K113306Cardio 7Bionet Co., Ltd. · 2012 · 2 generations on3descendants
- K220535Cardio10Bionet Co., Ltd. · 2022 · 3 generations on2descendants
- K131573CP150 ElectrocardiographWelch Allyn, Inc. · 2013 · cites it directly1descendant
- K231160Cardio Q50, Cardio Q70Bionet Co., Ltd. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895520 | Pagewriter Xli M1700A & Pagewriter XL M1701A | Hewlett-Packard Co. | 1990 | — |
| −2 | K020708 | Philips Pagewriter Touch Cardiograph, Model M5000A Series | Philips Medical Systems, Inc. | 2002 | 2 |
| −1 | K031422 | Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models… | Philips Medical Systems | 2003 | — |
| 0 (this device) | K072449 | CP100 & 200 12-Lead Resting Electrocardiographs | Welch Allyn, Inc. | 2007 | — |
| +1 | K102767 | Cardio XP | Bionet Co., Ltd. | 2011 | — |
| +2 | K113306 | Cardio 7 | Bionet Co., Ltd. | 2012 | — |
| +3 | K220535 | Cardio10 | Bionet Co., Ltd. | 2022 | — |
| +1 | K131573 | CP150 Electrocardiograph | Welch Allyn, Inc. | 2013 | — |
| +4 | K231160 | Cardio Q50, Cardio Q70 | Bionet Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K001265 | Welch Allyn Instrument Interface ModuleSummary page 1…G) Predicate Device: PageWriter Trim Series Cardiograph Philips Medical Systems 5 10(k) Number: K001265 Electrocardiograph, 21 CFR 870.2340 Class II, DPS… | 2000 |
| * | K031422 | Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models 860286, 860287…Summary page 1…Class II, DPS Medikro D9 Spirometer Caird Technology Inc 510O(k) Number: K03 1422 Diagnostic Spirometer, 21 CFR 868.1840 Class II, BZG Welch Allyn… | 2003 |
| † | K962854 | Hardware:Cardio Perfect Portable, Cardio Perfect MD and Software:Cardio Perfect (V. 4.0… | 1997 |
What descends from it? (7)
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 17 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K102767 (Bionet Co., Ltd., 2011) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K001265.
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 electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
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.
The optional Spirometry module is indicated for use in clinical situations to assess a patient's pulmonary health status and evaluate symptoms, signs, or abnormal laboratory test results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072449 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072449: CP100 & 200 12-Lead Resting Electrocardiographs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072449
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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