510(k) · Cleared
Recalled · Class I · 2019Advance Enforcer 35 Focal Force Pta Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · PNO Catheter, Percutaneous, Cutting/Scoring
Cleared on Mar 27, 2015 as substantially equivalent to K091527 (Cook, Inc., 2009) and 1 other predicate after a 311-day review. Its family tree reaches back 2 generations to 2009. 1 of the 3 devices in its family, counting itself, has a Class I recall. It has been recalled 3 times, including 3 Class I recalls.
- Decided
- Mar 27, 2015
- Review
- 311 days
- Class
- Class II
- Product code
- PNO
- Recalls
- 3 (3 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K091527 (2009). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK091527 Advance 35LP Low Profile Pta Balloon Dilatation CatheterCook, Inc. · 2009 · Recalled
- 1 generation backK132020 Advance 34LP Low Profile Pta Balloon Dilatation CatheterCook, Inc. · 2013
- This deviceK141322 Advance Enforcer 35 Focal Force Pta Balloon CatheterCook Incorporated · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K091527 | Advance 35LP Low Profile Pta Balloon Dilatation Catheter | Cook, Inc. | 2009 | 1 |
| −1 | K132020 | Advance 34LP Low Profile Pta Balloon Dilatation Catheter | Cook, Inc. | 2013 | — |
| 0 (this device) | K141322 | Advance Enforcer 35 Focal Force Pta Balloon Catheter | Cook Incorporated | 2015 | — |
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 PNO device
- #1 K261778 JADE SCORE PTA Scoring Balloon Dilatation…score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K091527 | Advance 35LP Low Profile Pta Balloon Dilatation CatheterSummary page 4…ect of this submission, is substantially equivalent to the predicate device, the Advance” 351LP Low Profile PTA Balloon Dilatation Catheters cleared under 510(k) numbers K091527 and K132020. Comparison to Predicate Device: It has been demonstrated that the Advance” Enforcer” 35 Focal Force PTA Balloon Ca… | 2009 |
| * | K132020 | Advance 34LP Low Profile Pta Balloon Dilatation CatheterSummary page 4…submission, is substantially equivalent to the predicate device, the Advance” 351LP Low Profile PTA Balloon Dilatation Catheters cleared under 510(k) numbers K091527 and K132020. Comparison to Predicate Device: It has been demonstrated that the Advance” Enforcer” 35 Focal Force PTA Balloon Catheters are… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 24, 2019 | Class I | Z-1758-2019 | Under Investigation by firm | Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and… |
| May 24, 2019 | Class I | Z-1757-2019 | Under Investigation by firm | Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and… |
| May 24, 2019 | Class I | Z-1756-2019 | Under Investigation by firm | Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K091527.
How does its category compare?
All PNO devicesPNO Catheter, Percutaneous, Cutting/Scoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PNO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNO
246in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PNO
No recall names PNO since 2007.
Adverse event reports per year · PNO
511in 2025
MAUDE reports naming product code PNO, 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 | 3 | 61 | 0 | 0 |
| 2008 | 4 | 28 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 23 | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 84 | 0 | 0 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 3 | 74 | 0 | 26 |
| 2018 | 0 | — | 0 | 55 |
| 2019 | 1 | — | 0 | 81 |
| 2020 | 4 | 94 | 0 | 121 |
| 2021 | 1 | — | 0 | 90 |
| 2022 | 2 | — | 0 | 75 |
| 2023 | 0 | — | 0 | 304 |
| 2024 | 4 | 246 | 0 | 537 |
| 2025 | 2 | — | 0 | 511 |
| 2026 | 3 | 110 | 0 | — |
What is it indicated for?
The Advance® Enforcer™ 35 Focal Force PTA Balloon Catheter is intended 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. Not for use in the cerebral or coronary vasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141322: Advance Enforcer 35 Focal Force Pta Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141322
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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