510(k) · Cleared
ClearedDisposable Temporary Pacing Cable,Models CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-Qloc-5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cp Medical · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Sep 19, 2002 after an 85-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Sep 19, 2002
- Review
- 85 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK022075 Disposable Temporary Pacing Cable,Models…Cp Medical · 2002
- Descendant · cites it directly · 1 of its ownK080621 Fastlock, Model PC175M01, PC175MCE, PC005R01European Custom Manufacturing BV · 2008
- Descendant · 2 generations on · 0 of its ownK200674 AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp -…Atrility Medical, LLC · 2020
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 |
|---|---|---|---|---|---|
| 0 (this device) | K022075 | Disposable Temporary Pacing Cable,Models… | Cp Medical | 2002 | — |
| +1 | K080621 | Fastlock, Model PC175M01, PC175MCE, PC005R01 | European Custom Manufacturing BV | 2008 | — |
| +2 | K200674 | AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable… | Atrility Medical, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2020 | 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 DSA? 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 DSA device
- #1 K252827 IBP cable Becton Dickinson (2606488); IBP…score 11.3 · 4 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 |
|---|---|---|---|
| * | — | Remington Medical, Inc. disposable Surgical Cable Named without a submission number | |
| * | — | Remington Medical, Inc. disposable Extension Cable Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080621 | Fastlock, Model PC175M01, PC175MCE, PC005R01 | 2008 | 1 |
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?
- Of its descendants, K080621 (European Custom Manufacturing BV, 2008) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DSA devicesDSA Cable, Transducer And Electrode, Patient, (Including Connector): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSA
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSA
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSA
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSA
67in 2025
MAUDE reports naming product code DSA, 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 | 2 | — | 0 | 4 |
| 2008 | 6 | 59 | 0 | 11 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 4 | 55 | 2 | 1 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 1 | — | 0 | 23 |
| 2014 | 1 | — | 0 | 67 |
| 2015 | 0 | — | 0 | 34 |
| 2016 | 2 | — | 0 | 28 |
| 2017 | 5 | 140 | 0 | 5 |
| 2018 | 3 | 84 | 0 | 16 |
| 2019 | 4 | 140 | 0 | 11 |
| 2020 | 6 | 177 | 0 | 31 |
| 2021 | 4 | 164 | 0 | 7 |
| 2022 | 2 | — | 1 | 49 |
| 2023 | 3 | 240 | 0 | 29 |
| 2024 | 3 | 102 | 0 | 40 |
| 2025 | 4 | 105 | 0 | 67 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
CP Medical's Disposable Temporary Pacing Cable with safety connectors is indicated for use as an electrical extension cable used to transmit signal from, or power or excitation signal to, patient-connected electrodes. The cable is bipolar, providing alligator clips at the end of the cable that will be attached to the patient's lead, and a safety plug at the other end that allows electrical connection to the external pacemaker or testing device, i.e.…
Read the full statement (136 words)
CP Medical's Disposable Temporary Pacing Cable with safety connectors is indicated for use as an electrical extension cable used to transmit signal from, or power or excitation signal to, patient-connected electrodes. The cable is bipolar, providing alligator clips at the end of the cable that will be attached to the patient's lead, and a safety plug at the other end that allows electrical connection to the external pacemaker or testing device, i.e., analyzer. The alligator clips are color-coded and imprinted with the polarity: The red clips are positive (+) and the black clips are negative (-).
The cable is designed to carry a maximum electrical load of 300 volts, and will be compatible with most external pacemakers, pace analyzers, and patient pacing leads currently on the market.
The cable is a sterile or nonsterile, disposable device
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022075 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022075: Disposable Temporary Pacing Cable,Models CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-Qloc-5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022075
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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