510(k) · Cleared
Recalled · Class II · 2025CP150 Electrocardiograph with Spirometry Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn · DPS Electrocardiograph
Cleared on Jul 11, 2014 as substantially equivalent to K131573 (Welch Allyn, Inc., 2013) after a 28-day review. Its family tree reaches back 5 generations to 1990. It has been recalled 2 times.
- Decided
- Jul 11, 2014
- Review
- 28 days
- Class
- Class II
- Product code
- DPS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K895520 (1990). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
- 4 generations backK020708 Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc. · 2002 · Recalled
- 3 generations backK031422 Philips Page Writer Trim Series Cardiograph Including I, II, Iii…Philips Medical Systems · 2003
- 2 generations backK072449 CP100 & 200 12-Lead Resting ElectrocardiographsWelch Allyn, Inc. · 2007
- 1 generation backK131573 CP150 ElectrocardiographWelch Allyn, Inc. · 2013
- This deviceK141582 CP150 Electrocardiograph with Spirometry OptionWelch Allyn · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K895520 | Pagewriter Xli M1700A & Pagewriter XL M1701A | Hewlett-Packard Co. | 1990 | — |
| −4 | K020708 | Philips Pagewriter Touch Cardiograph, Model M5000A Series | Philips Medical Systems, Inc. | 2002 | 2 |
| −3 | K031422 | Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models… | Philips Medical Systems | 2003 | — |
| −2 | K072449 | CP100 & 200 12-Lead Resting Electrocardiographs | Welch Allyn, Inc. | 2007 | — |
| −1 | K131573 | CP150 Electrocardiograph | Welch Allyn, Inc. | 2013 | — |
| 0 (this device) | K141582 | CP150 Electrocardiograph with Spirometry Option | Welch Allyn | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (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.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2025 | Class II | Z-1560-2025 | Process design | There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter. |
| Jun 3, 2024 | Class II | Z-2323-2024 | Employee error | During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The purpose of the EMI absorber is to prevent EMI leakage that might potentially affect other devices in the vicinity or the device… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
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 electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function. The 12-lead optional interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information. The Spirometer is a device that measures lung air volume and airflow rate for pulmonary disease diagnosis and screening.…
Read the full statement (112 words)
The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
The 12-lead optional interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.
The Spirometer is a device that measures lung air volume and airflow rate for pulmonary disease diagnosis and screening. These measurements provide information about a patient's pulmonary function which may be compared with normal values or the patient's previous values. The device is designed to test pulmonary function and obtain spirometric indices for:
* adult and pediatric patients 12 years and older,
* hospital and clinic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141582: CP150 Electrocardiograph with Spirometry Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141582
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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