510(k) · Cleared
ClearedAtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atrility Medical, LLC · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Jul 2, 2020 as substantially equivalent to K080621 (European Custom Manufacturing BV, 2008) and 1 other predicate after a 108-day review. Its family tree reaches back 2 generations to 2002. 1 of the 4 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 2, 2020
- Review
- 108 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K022075 (2002). 3 ancestors in all. No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK022075 Disposable Temporary Pacing Cable,Models…Cp Medical · 2002
- 1 generation backK080621 Fastlock, Model PC175M01, PC175MCE, PC005R01European Custom Manufacturing BV · 2008
- This deviceK200674 AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp -…Atrility Medical, LLC · 2020
Class I recalls in this family
- K070926 Electrode/Extension Cables, Models Atardirect predicate · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022075 | Disposable Temporary Pacing Cable,Models… | Cp Medical | 2002 | — |
| −1 | K080621 | Fastlock, Model PC175M01, PC175MCE, PC005R01 | European Custom Manufacturing BV | 2008 | — |
| 0 (this device) | K200674 | AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable… | Atrility Medical, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K080621 | Fastlock, Model PC175M01, PC175MCE, PC005R01Summary page 4…ducer and electrode cable (including connector) Product Code: DSA, Class II Predicate Devices: K080621, Fastlock Pacing Wire Extension (Primary Predicate) K070926, Electrode/Extension C… | 2008 |
| * | K070926 | Electrode/Extension Cables, Models AtarSummary page 4…: DSA, Class II Predicate Devices: K080621, Fastlock Pacing Wire Extension (Primary Predicate) K070926, Electrode/Extension Cables, Model series ATAR Device Description The AtriAmp acts as a connecti… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K070926Electrode/Extension Cables, Models AtarOscor, Inc. · 2007 · Direct predicate · ◆ in the 2007 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 12.2 years on median.
- 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
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. 2020, 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?
The AtriAmp supports pacing by acting as an extension cable between an external pacemaker and cardiac pacing leads.
The AtriAmp also supports monitoring of intra-cardiac signals by transmitting signals to one of the unipolar precordial chest leads (leads V1-V6) of a Type CF, defibrillation-proof ECG monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200674: AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200674
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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