510(k) · Cleared
ClearedPheron Pta Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DQY Catheter, Percutaneous
Cleared on Oct 31, 2003 as substantially equivalent to K010838 (Jomed AG, 2001) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 2000. 8 later devices descend from it.
- Decided
- Oct 31, 2003
- Review
- 28 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000101 (2000). 4 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK000101 RX Viatrac 14 Peripheral Dilatation CatheterGuidant Corp. · 2000
- 1 generation backK020854 Modification to Fox Pta CatheterJomed AG · 2002
- This deviceK033217 Pheron Pta CatheterBiotronik, Inc. · 2003
- Descendant · cites it directly · 7 of its ownK072765 Passeo 18Biotronik, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK082933 Passeo-35 Pta CatheterBiotronik, Inc. · 2008
- Descendant · 2 generations on · 3 of its ownK142379 Passeo-35 PTA CatheterBiotronik, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK222065 Passeo-35 Xeo Peripheral Dilatation CatheterBiotronik, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK151744 Passeo-18 Peripheral Dilation CatheterBiotronik, Inc. · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K072765Passeo 18Biotronik, Inc. · 2007 · cites it directly7descendants
- K082933Passeo-35 Pta CatheterBiotronik, Inc. · 2008 · cites it directly5descendants
- K142379Passeo-35 PTA CatheterBiotronik, Inc. · 2014 · 2 generations on3descendants
- K222065Passeo-35 Xeo Peripheral Dilatation CatheterBiotronik, Inc. · 2023 · 3 generations on1descendant
- K151744Passeo-18 Peripheral Dilation CatheterBiotronik, Inc. · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000101 | RX Viatrac 14 Peripheral Dilatation Catheter | Guidant Corp. | 2000 | — |
| −1 | K020854 | Modification to Fox Pta Catheter | Jomed AG | 2002 | — |
| 0 (this device) | K033217 | Pheron Pta Catheter | Biotronik, Inc. | 2003 | — |
| +1 | K072765 | Passeo 18 | Biotronik, Inc. | 2007 | — |
| +1 | K082933 | Passeo-35 Pta Catheter | Biotronik, Inc. | 2008 | — |
| +2 | K142379 | Passeo-35 PTA Catheter | Biotronik, Inc. | 2014 | — |
| +3 | K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter | Biotronik, Inc. | 2023 | — |
| +2 | K151744 | Passeo-18 Peripheral Dilation Catheter | Biotronik, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K010838 | Fox Pta Catheter, 3.0, 4.0, 5.0, 6.0, 7.0, and 8.0 X 40 MM, Models A14003, A14004…Summary page 1…the following PTA catheter cleared through 51O(k) notifications as a predicate device for the Pheron Peripheral PTA Catheter: Jomed AG's Fox PTA catheter (K010838, cleared 06-21-01 and K020854, cleared 04-11-02)… | 2001 |
| * | K020854 | Modification to Fox Pta CatheterSummary page 1…eared through 51O(k) notifications as a predicate device for the Pheron Peripheral PTA Catheter: Jomed AG's Fox PTA catheter (K010838, cleared 06-21-01 and K020854, cleared 04-11-02) z Indication… | 2002 |
What descends from it? (8)
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?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K072765 (Biotronik, Inc., 2007) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K010838.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Pheron PTA balloon catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033217 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033217: Pheron Pta Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033217
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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