510(k) · Cleared
ClearedMedivalve Acwire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medivalve, Ltd. · DQX Wire, Guide, Catheter
Cleared on Nov 8, 2013 as substantially equivalent to K062192 (Ostial Solutions, LLC, 2007) after an 87-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Nov 8, 2013
- Review
- 87 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K970376 (1997). 17 ancestors in all, the oldest K893626 (1989). No later device cites it as a predicate yet.
- Root · 5 generations backK970376 Ptca GuidewireLake Region Mfg., Inc. · 1997
- 4 generations backK011968 Streerable Ptca GuidewireLake Region Mfg., Inc. · 2001 · Recalled
- 3 generations backK022813 Steerable GuidewireLake Region Mfg., Inc. · 2003
- 2 generations backK042338 Coronary Peripheral and Renal Steerable GuidewireLake Region Mfg., Inc. · 2004
- 1 generation backK062192 Ostial Pro Stent Positioning SystemOstial Solutions, LLC · 2007
- This deviceK132545 Medivalve AcwireMedivalve, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970376 | Ptca Guidewire | Lake Region Mfg., Inc. | 1997 | — |
| −4 | K011968 | Streerable Ptca Guidewire | Lake Region Mfg., Inc. | 2001 | 2 |
| −3 | K022813 | Steerable Guidewire | Lake Region Mfg., Inc. | 2003 | — |
| −2 | K042338 | Coronary Peripheral and Renal Steerable Guidewire | Lake Region Mfg., Inc. | 2004 | — |
| −1 | K062192 | Ostial Pro Stent Positioning System | Ostial Solutions, LLC | 2007 | — |
| 0 (this device) | K132545 | Medivalve Acwire | Medivalve, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2006 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062192 | Ostial Pro Stent Positioning System | 2007 |
| Kept off the family tree | K001084 | FDA’s K001084 is Trans FX Adjustable Pin to Bar Clamp Our reading of the summary gave K001084, FDA’s number for Trans FX Adjustable Pin to Bar Clamp (Immedica, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Lake Region Manufacturing (LRM) Catheter Guidewire”. Kept off the family tree. | 2000 |
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 16 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 17 ancestors has a recall of any class.
- 3 other devices also cite its predicate K062192.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 acWire is intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices. The acWire may also function as an alignment tool by providing a reference plane of anatomical structures of interest (e.g., the aortic valve).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132545 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132545: Medivalve Acwire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132545
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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