510(k) · Cleared
ClearedOptimus 0.035 Pta Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usci Ireland · DQY Catheter, Percutaneous
Cleared on Nov 3, 2008 as substantially equivalent to K072156 (Usci Ireland, 2007) and 2 other predicates after a 53-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Nov 3, 2008
- Review
- 53 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K032737 (2003). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK032737 Cordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus…Cordis Europa, N.V. · 2003 · Recalled
- 1 generation backK072156 Optimus 0.035 Inch Pta Balloon Dilatation CatheterUsci Ireland · 2007
- This deviceK082646 Optimus 0.035 Pta Balloon Dilatation CatheterUsci Ireland · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032737 | Cordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus Pta… | Cordis Europa, N.V. | 2003 | 1 |
| −1 | K072156 | Optimus 0.035 Inch Pta Balloon Dilatation Catheter | Usci Ireland | 2007 | — |
| 0 (this device) | K082646 | Optimus 0.035 Pta Balloon Dilatation Catheter | Usci Ireland | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (3)
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 |
|---|---|---|---|
| * | K072156 | Optimus 0.035 Inch Pta Balloon Dilatation CatheterSummary page 1…OPTIMUS 0.035" PTA Balloon Dilatation Catheter 510(k) Clearance Number: K072156 Device Name: Cordis OPTA PRO PTA Catheter 510(k) Clearance Number:… | 2007 |
| * | K032737 | Cordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus Pta Balloon…Summary page 1…Clearance Number: K072156 Device Name: Cordis OPTA PRO PTA Catheter 510(k) Clearance Number: K032737 Device Name: Invatec SAILOR PLUS PTA Catheter 510(k) Clearance Number:… | 2003 |
| * | K042538 | Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model SaexxxxxxxxxSummary page 1…ance Number: K032737 Device Name: Invatec SAILOR PLUS PTA Catheter 510(k) Clearance Number: K042538 USCI Ireland IDA Business Park, Ballinasloe, Co Galway, Irel… | 2004 |
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 5 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 3 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. 2008, 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 OPTIMUS 0.035" PTA Balloon Dilatation Catheter is intended to dilate stenoses in the Iliac, Femoral, Popliteal and Renal arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082646 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082646: Optimus 0.035 Pta Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082646
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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