510(k) · Cleared
ClearedGliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trireme Medical, Inc. · DQY Catheter, Percutaneous
Cleared on Aug 17, 2011 as substantially equivalent to K082343 (Ymed, Inc., 2008) and 3 other predicates after an 8-day review. Its family tree reaches back 8 generations to 2000. 4 later devices descend from it.
- Decided
- Aug 17, 2011
- Review
- 8 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K001134 (2000). 35 ancestors in all, the oldest K945904 (1995). 4 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 7 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 6 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 5 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 4 generations backK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
- 3 generations backK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
- 2 generations backK101062 Glider Pta Balloon CatheterTrireme Medical, Inc. · 2010
- 1 generation backK103534 Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018…Trireme Medical, Inc. · 2011
- This deviceK112281 Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire…Trireme Medical, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK121402 Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire…Trireme Medical, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK122070 Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire…Trireme Medical, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK130414 Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire…Trireme Medical, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK213631 Chocolate PTA Balloon CatheterMedtronic, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…Trireme Medical, Inc. · 2012 · cites it directly3descendants
- K122070Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc. · 2012 · cites it directly2descendants
- K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc. · 2013 · 2 generations on1descendant
- K213631Chocolate PTA Balloon CatheterMedtronic, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −7 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −6 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −5 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −4 | K072283 | Dorado Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2007 | 15 |
| −3 | K082579 | Evercross .035 Otw Pta Dilatation Catheter | Ev3, Inc. | 2008 | 1 |
| −2 | K101062 | Glider Pta Balloon Catheter | Trireme Medical, Inc. | 2010 | — |
| −1 | K103534 | Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide Wire | Trireme Medical, Inc. | 2011 | — |
| 0 (this device) | K112281 | Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx… | Trireme Medical, Inc. | 2011 | — |
| +1 | K121402 | Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta… | Trireme Medical, Inc. | 2012 | — |
| +1 | K122070 | Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta… | Trireme Medical, Inc. | 2012 | — |
| +2 | K130414 | Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta… | Trireme Medical, Inc. | 2013 | — |
| +3 | K213631 | Chocolate PTA Balloon Catheter | Medtronic, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1997 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2021 | 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? (4)
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 |
|---|---|---|---|
| * | K082343 | Vascutrak 2, Models: V14 and V18Summary page 1…utaneous Catheter (21 CFR 870.1250) Product Code: DQY / LIT 5 10(k) number: Predicate Devices: VascuTraik PTA Dilatation Catheter (K082343) EverCross 0.035" OTW PTA Dilatation Catheter (K0825 19)… | 2008 |
| * | K082519 | Finecross MG Coronary Micro-Guide CatheterSummary page 1…k) number: Predicate Devices: VascuTraik PTA Dilatation Catheter (K082343) EverCross 0.035" OTW PTA Dilatation Catheter (K0825 19) GliderXtreme PTA Balloon Catheter (K 10 1062) Gliderfi… | 2008 |
| * | K101062 | Glider Pta Balloon CatheterSummary page 1…343) EverCross 0.035" OTW PTA Dilatation Catheter (K0825 19) GliderXtreme PTA Balloon Catheter (K 10 1062) GliderfieX PTA Balloon Catheter (K1 03534) 3. Intended Use The PTA Balloo… | 2010 |
| * | K103534 | Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide WireSummary page 1…heter (K0825 19) GliderXtreme PTA Balloon Catheter (K 10 1062) GliderfieX PTA Balloon Catheter (K1 03534) 3. Intended Use The PTA Balloon Catheter famnily is intended for balloon dilatation of lesions in the… | 2011 |
What descends from it? (4)
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 11 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 35 ancestors have a recall of any class.
- Of its descendants, K121402 (Trireme Medical, Inc., 2012) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K082343.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 PTA Balloon Catheter Family of devices, including the GliderXtreme PTA Balloon Catheter and the GliderfieX PTA Balloon Catheter are intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.
The indication for use is same for all devices in the PTA Balloon Catheter Family.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112281: Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112281
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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