510(k) · Cleared
ClearedGlider Pta Balloon Catheter
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 Feb 12, 2010 as substantially equivalent to K090849 (Ev3, Inc., 2009) and 1 other predicate after a 45-day review. Its family tree reaches back 5 generations to 2000. 4 later devices descend from it.
- Decided
- Feb 12, 2010
- Review
- 45 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001134 (2000). 7 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 4 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 3 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 2 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 1 generation backK080982 Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation…Boston Scientific Corp · 2008
- This deviceK094019 Glider Pta Balloon CatheterTrireme Medical, Inc. · 2010
- 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 |
|---|---|---|---|---|---|
| −5 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −4 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −3 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −2 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −1 | K080982 | Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters | Boston Scientific Corp | 2008 | — |
| 0 (this device) | K094019 | Glider Pta Balloon Catheter | Trireme Medical, Inc. | 2010 | — |
| +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 |
|---|---|---|
| 2008 | 1 | 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? (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 |
|---|---|---|---|
| * | K090849 | Modification to: Nanocross 0.14 Otw Pta Dilatation Catheter, Models AB14W020210090…Summary page 1…Product Code: DQY / LIT Predicate Devices: NanoCross PTA Dilatation Catheter (K090849) Sterling ES MR and OTW PTA Balloon Dilatation Catheters… | 2009 |
| * | K080982 | Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation CathetersSummary page 1…Sterling ES MR and OTW PTA Balloon Dilatation Catheters (K080982) 3. Intended Use The GliderTm PTA Balloon Catheter is intended for bal… | 2008 |
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 10 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K121402 (Trireme Medical, Inc., 2012) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K090849.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 GliderTM PTA Balloon Catheter is 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K094019 · printed Nov 4, 2026
Cite this page
510(k) Report. “K094019: Glider Pta Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K094019
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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