510(k) · Cleared
Cleared12-Lead Resting Electrocardiograph, Models CP100 & CP200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · DPS Electrocardiograph
Cleared on Mar 22, 2005 as substantially equivalent to K031422 (Philips Medical Systems, 2003) and 1 other predicate after a 69-day review. Its family tree reaches back 3 generations to 1990. 12 later devices descend from it.
- Decided
- Mar 22, 2005
- Review
- 69 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. 12 later devices descend from it, 1 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 deviceK050074 12-Lead Resting Electrocardiograph, Models CP100 & CP200Welch Allyn, Inc. · 2005
- Descendant · cites it directly · 11 of its ownK060167 Atria 3100, Atria 6100Cardiac Science Corporation · 2006
- Descendant · 2 generations on · 8 of its ownK160876 PC ECGEdan Instruments, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK171942 ElectrocardiographEdan Instruments, Inc. · 2018
- Descendant · 3 generations on · 3 of its ownK170995 ElectrocardiographEdan Instruments, Inc. · 2017
- Descendant · 4 generations on · 2 of its ownK212278 ElectrocardiographEdan Instruments, Inc. · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K060167Atria 3100, Atria 6100Cardiac Science Corporation · 2006 · cites it directly11descendants
- K160876PC ECGEdan Instruments, Inc. · 2017 · 2 generations on8descendants
- K171942ElectrocardiographEdan Instruments, Inc. · 2018 · 3 generations on3descendants
- K170995ElectrocardiographEdan Instruments, Inc. · 2017 · 3 generations on3descendants
- K212278ElectrocardiographEdan Instruments, Inc. · 2022 · 4 generations on2descendants
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) | K050074 | 12-Lead Resting Electrocardiograph, Models CP100 & CP200 | Welch Allyn, Inc. | 2005 | — |
| +1 | K060167 | Atria 3100, Atria 6100 | Cardiac Science Corporation | 2006 | — |
| +2 | K160876 | PC ECG | Edan Instruments, Inc. | 2017 | — |
| +3 | K171942 | Electrocardiograph | Edan Instruments, Inc. | 2018 | — |
| +3 | K170995 | Electrocardiograph | Edan Instruments, Inc. | 2017 | — |
| +4 | K212278 | Electrocardiograph | Edan Instruments, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K031422 | Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models 860286, 860287…Summary page 1…ly Predicate Device: The legally marketed medical devices equivalent to the following: * PageWriter Trim Series Cardiograph (K(031422) * Spirometer System (Medikro D9 Spirometer) (K971336) Description: The Welch Al… | 2003 |
| * | K971336 | Caird Technology SpirometerSummary page 1…t to the following: * PageWriter Trim Series Cardiograph (K(031422) * Spirometer System (Medikro D9 Spirometer) (K971336) Description: The Welch Allyn Multi-Channel Electrocardiographs, the low cost CP 100 or… | 1998 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060167 | Atria 3100, Atria 6100 | 2006 | 11 |
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 15 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K060167 (Cardiac Science Corporation, 2006) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K031422.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Welch Allyn Printing Electrocardiography and Spirometry Products (Subject Devices) are intended for use by trained operators in health facilities. The subject Devices will provide the following diagnostic functions: * Acquiring, viewing, storing and printing ECG waveforms patients using ECG Front End modules and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ECG waveforms through surface electrodes…
Read the full statement (222 words)
The Welch Allyn Printing Electrocardiography and Spirometry Products (Subject Devices) are intended for use by trained operators in health facilities. The subject Devices will provide the following diagnostic functions:
* Acquiring, viewing, storing and printing ECG waveforms patients using ECG Front End modules and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body.
* Using optional algorithms to generate measurements, data presentations, graphical presentations and interpretive statements on an advisory basis for patients of sixteen (16) years of age and above. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings.
* Using the optional Spirometry module and associated accessories to acquire, view, store and print measures and waveforms of pulmonary function including, but not limited to, maximal volume and flow of air that can be moved in and out of a patient's lungs. These measures are used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases. The Spirometer may be used with patients that are able to understand the instructions for performing the test, however normal values and interpretive results are not calculated for children under the age of six.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050074: 12-Lead Resting Electrocardiograph, Models CP100 & CP200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050074
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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