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. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on May 12, 2010 as substantially equivalent to K090849 (Ev3, Inc., 2009) and 2 other predicates after a 26-day review. Its family tree reaches back 6 generations to 2000. 8 later devices descend from it.
- Decided
- May 12, 2010
- Review
- 26 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K001134 (2000). 17 ancestors in all. 8 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 5 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 4 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 3 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 2 generations backK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
- 1 generation backK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
- This deviceK101062 Glider Pta Balloon CatheterTrireme Medical, Inc. · 2010
- Descendant · cites it directly · 6 of its ownK103534 Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018…Trireme Medical, Inc. · 2011
- Descendant · cites it directly · 5 of its ownK111738 Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and…Trireme Medical, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK120677 Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014)Trireme Medical, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK112281 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K103534Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide WireTrireme Medical, Inc. · 2011 · cites it directly6descendants
- K111738Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018)Trireme Medical, Inc. · 2011 · cites it directly5descendants
- K120677Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014)Trireme Medical, Inc. · 2012 · cites it directly4descendants
- K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXXTrireme Medical, Inc. · 2011 · cites it directly4descendants
- K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…Trireme Medical, Inc. · 2012 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −5 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −4 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −3 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −2 | K072283 | Dorado Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2007 | 15 |
| −1 | K082579 | Evercross .035 Otw Pta Dilatation Catheter | Ev3, Inc. | 2008 | 1 |
| 0 (this device) | 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 | — |
| +1 | K111738 | Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018) | Trireme Medical, Inc. | 2011 | — |
| +1 | K120677 | Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014) | Trireme Medical, Inc. | 2012 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 3 | 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 LIT? 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 LIT device
- #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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…ation Name: Percutaneous Catheter (21 CER 870.1250) Product Code: DQY /LIT 5 10(k) number: Predicate Devices: NanoCross PTA Dilatation Catheter (K090849) Sterling ES MR and OTW PTA Balloon Dilatation Catheters (1(080982)… | 2009 |
| * | K080982 | Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation CathetersSummary page 1…ces: NanoCross PTA Dilatation Catheter (K090849) Sterling ES MR and OTW PTA Balloon Dilatation Catheters (1(080982) EverCross .035" OTW PTA Dilatation Catheter (K(082579) 3. Intended Use The GliderXtremeTM PTA… | 2008 |
| * | K082579 | Evercross .035 Otw Pta Dilatation CatheterSummary page 1…terling ES MR and OTW PTA Balloon Dilatation Catheters (1(080982) EverCross .035" OTW PTA Dilatation Catheter (K(082579) 3. Intended Use The GliderXtremeTM PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral… | 2008 |
What descends from it? (8)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103534 | Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide Wire | 2011 | 6 |
| K111738 | Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018) | 2011 | 5 |
| K120677 | Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014) | 2012 | 4 |
| K112281 | Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXX | 2011 | 4 |
| K121402 | Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon… | 2012 | 3 |
| K122070 | Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon… | 2012 | 2 |
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 5 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 17 ancestors have a recall of any class.
- Of its descendants, K103534 (Trireme Medical, Inc., 2011) has gone furthest, with 6 descendants of its own.
- 8 other devices also cite its predicate K090849.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LIT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LIT
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIT
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LIT
2,073in 2025
MAUDE reports naming product code LIT, 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 | 6 | 64 | 0 | 577 |
| 2008 | 8 | 53 | 0 | 513 |
| 2009 | 7 | 29 | 2 | 623 |
| 2010 | 13 | 78 | 1 | 809 |
| 2011 | 10 | 82 | 0 | 857 |
| 2012 | 19 | 29 | 0 | 1,277 |
| 2013 | 14 | 79 | 2 (2) | 1,242 |
| 2014 | 12 | 90 | 3 | 1,178 |
| 2015 | 19 | 112 | 0 | 1,279 |
| 2016 | 11 | 116 | 1 | 1,529 |
| 2017 | 9 | 57 | 0 | 2,081 |
| 2018 | 6 | 118 | 2 | 2,188 |
| 2019 | 4 | 40 | 3 | 2,405 |
| 2020 | 9 | 125 | 0 | 2,443 |
| 2021 | 4 | 61 | 1 | 2,492 |
| 2022 | 8 | 122 | 0 | 2,155 |
| 2023 | 6 | 167 | 0 | 1,807 |
| 2024 | 6 | 43 | 2 | 1,913 |
| 2025 | 3 | 90 | 1 | 2,073 |
| 2026 | 4 | 205 | 0 | — |
What is it indicated for?
The Glider 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.
The indication for use is same for all Glider PTA Balloon Catheter Family.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101062: Glider 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/K101062
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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