510(k) · Cleared
Recalled · Class II · 2018Advance 35LP Low Profile Pta Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · DQY Catheter, Percutaneous
Cleared on Jun 12, 2009 after a 17-day review. The FDA summary names its predicate without a number. 1 of the 3 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 12, 2009
- Review
- 17 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 2 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- This deviceK091527 Advance 35LP Low Profile Pta Balloon Dilatation CatheterCook, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK132020 Advance 34LP Low Profile Pta Balloon Dilatation CatheterCook, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK141322 Advance Enforcer 35 Focal Force Pta Balloon CatheterCook Incorporated · 2015 · Recalled (Class I)
Class I recalls in this family
- K141322 Advance Enforcer 35 Focal Force Pta Balloon…cites it directly · 2015
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 |
|---|---|---|---|---|---|
| 0 (this device) | K091527 | Advance 35LP Low Profile Pta Balloon Dilatation Catheter | Cook, Inc. | 2009 | — |
| +1 | K132020 | Advance 34LP Low Profile Pta Balloon Dilatation Catheter | Cook, Inc. | 2013 | — |
| +1 | K141322 | Advance Enforcer 35 Focal Force Pta Balloon Catheter | Cook Incorporated | 2015 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | — | PTA Balloon Catheter Named without a submission number |
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? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 16, 2018 | Class II | Z-1521-2018 | Labeling mix-ups | Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K141322Advance Enforcer 35 Focal Force Pta Balloon CatheterCook Incorporated · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- Of its descendants, K132020 (Cook, Inc., 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091527: Advance 35LP Low Profile Pta Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091527
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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