510(k) · Cleared
ClearedAdvance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model PTA3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · DQY Catheter, Percutaneous
Cleared on Mar 19, 2013 as substantially equivalent to K090822 (Cook, Inc., 2009) after a 176-day review. Its family tree reaches back 1 generation to 2009. 2 later devices descend from it.
- Decided
- Mar 19, 2013
- Review
- 176 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K090822 (2009). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK090822 Advance 14RX Rapid Exchange Pta Balloon CatheterCook, Inc. · 2009
- This deviceK122940 Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model…Cook, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK152934 MMS PTA Balloon CatheterMicro Medical Solutions, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK140593 Advance Salivary Balloon Catheter with Wire GuideCook, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K090822 | Advance 14RX Rapid Exchange Pta Balloon Catheter | Cook, Inc. | 2009 | — |
| 0 (this device) | K122940 | Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model PTA3 | Cook, Inc. | 2013 | — |
| +1 | K152934 | MMS PTA Balloon Catheter | Micro Medical Solutions, Inc. | 2016 | — |
| +1 | K140593 | Advance Salivary Balloon Catheter with Wire Guide | Cook, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K090822 | Advance 14RX Rapid Exchange Pta Balloon CatheterSummary page 1…21 CFR §870.1250 Product Code: DQY, LIT Predicate Device: Advance I4LP Low Profile PTA Balloon Dilatation Catheter D.C. #K090822, April 27, 2009 Cook Incorporated Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter Traditional 510(k) De… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including internal pudendal, iliac, renal, popliteal, femoral, iliofemoral, anterior tibial, posterior tibial, peroneal, pedal, radial, brachial, and ulnar, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122940 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122940: Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model PTA3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122940
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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