510(k) · Cleared
ClearedPerfect-O Ostial Positioning Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Balosmark, Inc. · DQY Catheter, Percutaneous
Cleared on Jun 5, 2026 as substantially equivalent to K122089 (Merit Medical Systems, Inc., 2012) after a 127-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Jun 5, 2026
- Review
- 127 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K970376 (1997). 18 ancestors in all, the oldest K893626 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK970376 Ptca GuidewireLake Region Mfg., Inc. · 1997
- 5 generations backK011968 Streerable Ptca GuidewireLake Region Mfg., Inc. · 2001 · Recalled
- 4 generations backK022813 Steerable GuidewireLake Region Mfg., Inc. · 2003
- 3 generations backK042338 Coronary Peripheral and Renal Steerable GuidewireLake Region Mfg., Inc. · 2004
- 2 generations backK062192 Ostial Pro Stent Positioning SystemOstial Solutions, LLC · 2007
- 1 generation backK122089 Ostial Pro Stent Positioning SystemMerit Medical Systems, Inc. · 2012
- This deviceK260289 Perfect-O Ostial Positioning CatheterBalosmark, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970376 | Ptca Guidewire | Lake Region Mfg., Inc. | 1997 | — |
| −5 | K011968 | Streerable Ptca Guidewire | Lake Region Mfg., Inc. | 2001 | 2 |
| −4 | K022813 | Steerable Guidewire | Lake Region Mfg., Inc. | 2003 | — |
| −3 | K042338 | Coronary Peripheral and Renal Steerable Guidewire | Lake Region Mfg., Inc. | 2004 | — |
| −2 | K062192 | Ostial Pro Stent Positioning System | Ostial Solutions, LLC | 2007 | — |
| −1 | K122089 | Ostial Pro Stent Positioning System | Merit Medical Systems, Inc. | 2012 | — |
| 0 (this device) | 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 |
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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 |
|---|---|---|---|
| * | K122089 | Ostial Pro Stent Positioning SystemSummary page 5…O Ostial Positioning Catheter Common / Usual Name Percutaneous Catheter Classification Name 21 CFR 870.1250, DQY, Class II Predicate Device K122089, Ostial Pro Stent Positioning System (Merit Medical Systems, Inc) Device Description The Perfect-O is a medical-grade, disposa… | 2012 |
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 29 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 18 ancestors has a recall of any class.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Perfect-O Ostial Positioning Catheter is intended for use in aorto-ostial procedures to introduce and position stents and other interventional devices within the coronary and peripheral vasculature. In addition, the Perfect-O Ostial Positioning Catheter is intended to facilitate the alignment of interventional devices and function as an alignment tool. The Perfect-O Ostial Positioning Catheter is not intended for use and has not been evaluated for use in the neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260289 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260289: Perfect-O Ostial Positioning Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260289
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026