510(k) · Cleared
ClearedFastlock, Model PC175M01, PC175MCE, PC005R01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
European Custom Manufacturing BV · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Apr 29, 2008 as substantially equivalent to K022075 (Cp Medical, 2002) after a 55-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.
- Decided
- Apr 29, 2008
- Review
- 55 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022075 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK022075 Disposable Temporary Pacing Cable,Models…Cp Medical · 2002
- This deviceK080621 Fastlock, Model PC175M01, PC175MCE, PC005R01European Custom Manufacturing BV · 2008
- Descendant · cites it directly · 0 of its ownK200674 AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp -…Atrility Medical, LLC · 2020
Most influential descendants
Showing 1 of 1 · See all- K200674AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor…Atrility Medical, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022075 | Disposable Temporary Pacing Cable,Models… | Cp Medical | 2002 | — |
| 0 (this device) | K080621 | Fastlock, Model PC175M01, PC175MCE, PC005R01 | European Custom Manufacturing BV | 2008 | — |
| +1 | 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 |
|---|---|---|
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022075 | Disposable Temporary Pacing Cable,Models…Summary page 3…FastLock Etnsion DisposableTepry Cabl Pacing Cable 510(k) Number K022075 Manufacturer European Custom CP Medical, Inc. Manufacturing BV Classification #& 8… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200674 | AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor… | 2020 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K200674 (Atrility Medical, LLC, 2020) has gone furthest, with 0 descendants 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. 2008, this device’s year, is highlighted.
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?
Fastlock pacing wire extension cable with connectors is indicated for use as an electrical extension cable used to transmit signal from, or power or excitation signal to patient-connected electrodes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080621: Fastlock, Model PC175M01, PC175MCE, PC005R01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080621
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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