510(k) · Cleared
ClearedProTrack Pigtail Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Company, Inc. · DQX Wire, Guide, Catheter
Cleared on Mar 1, 2023 as substantially equivalent to K132623 (Medtronic, 2013) after a 442-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Mar 1, 2023
- Review
- 442 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K920884 (1992). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK920884 Guidewires, Various TypesAcme-Monaco Corp. · 1992
- 3 generations backK982559 GuidewireGalt Medical Corp. · 1999 · Recalled
- 2 generations backK042370 Torayguide GuidewireToray Industries (America), Inc. · 2004
- 1 generation backK132623 Medtronic Confida Brecker Curve GuidewireMedtronic · 2013
- This deviceK213898 ProTrack Pigtail WireBaylis Medical Company, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920884 | Guidewires, Various Types | Acme-Monaco Corp. | 1992 | — |
| −3 | K982559 | Guidewire | Galt Medical Corp. | 1999 | 1 |
| −2 | K042370 | Torayguide Guidewire | Toray Industries (America), Inc. | 2004 | — |
| −1 | K132623 | Medtronic Confida Brecker Curve Guidewire | Medtronic | 2013 | — |
| 0 (this device) | K213898 | ProTrack Pigtail Wire | Baylis Medical Company, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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 DQX? 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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 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 |
|---|---|---|---|
| * | K132623 | Medtronic Confida Brecker Curve GuidewireSummary page 4…evice A. Predicate Device: Medtronic ConfidaTM Brecker CurveTM Guidewire B. Manufacturer: Medtronic C. 510(k) K132623 D. Indications for Use The Medtronic ConfidaTM Brecker CurveTM Guidewire is inte… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 5 companies; a new generation was cleared every 9.0 years on median.
- 4 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K132623.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
The ProTrack™ Pigtail Wires are intended for use to introduce and position catheters and other interventional devices within the chambers of the heart, including those used within transcatheter aortic valve procedures (TAVR).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213898 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213898: ProTrack Pigtail Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213898
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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