510(k) · Cleared
ClearedOstial Pro Stent Positioning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · DQX Wire, Guide, Catheter
Cleared on Sep 21, 2012 as substantially equivalent to K062192 (Ostial Solutions, LLC, 2007) after a 67-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- Sep 21, 2012
- Review
- 67 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K970376 (1997). 17 ancestors in all, the oldest K893626 (1989). 1 later device descends from it, 1 citing it directly.
- 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 deviceK122089 Ostial Pro Stent Positioning SystemMerit Medical Systems, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK260289 Perfect-O Ostial Positioning CatheterBalosmark, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260289Perfect-O Ostial Positioning CatheterBalosmark, Inc. · 2026 · cites it directly0descendants
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) | K122089 | Ostial Pro Stent Positioning System | Merit Medical Systems, Inc. | 2012 | — |
| +1 | K260289 | Perfect-O Ostial Positioning Catheter | Balosmark, Inc. | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K062192 | Ostial Pro Stent Positioning SystemSummary page 1…stem Common/Usual Name: Stent Positioning System Predicate Device Classification Name: Catheter Guidewire Premarket Notification: K0621 92 Manufacturer: Merit Medical Systems, Inc. Class 11 Classification 21 CER §… | 2007 |
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 |
|---|---|---|---|
| K260289 | Perfect-O Ostial Positioning Catheter | 2026 | 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?
- The line of descent spans 15 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.
- Of its descendants, K260289 (Balosmark, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 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. 2012, 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 Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position stents; and other interventional devices within the coronary and peripheral vasculature. In addition, the Ostial Pro Stent Positioning System is intended to facilitate the alignment of interventional devices and function as an alignment tool.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122089 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122089: Ostial Pro Stent Positioning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122089
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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