510(k) · Cleared
ClearedAdmiral Xtreme Pta Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invatec S.P.A. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Apr 30, 2010 as substantially equivalent to K062809 (Invatec Innovative Technologies, 2006) after a 28-day review. Its family tree reaches back 2 generations to 2004. 12 later devices descend from it.
- Decided
- Apr 30, 2010
- Review
- 28 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042538 (2004). 12 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK042538 Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
- 1 generation backK062809 Admiral Xtreme Pta CatheterInvatec Innovative Technologies · 2006
- This deviceK100921 Admiral Xtreme Pta Balloon Dilatation CatheterInvatec S.P.A. · 2010
- Descendant · cites it directly · 9 of its ownK103464 Pacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 6 of its ownK133843 Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · Recalled
- Descendant · 3 generations on · 4 of its ownK151153 Pirouette 018Arravasc Limited · 2015
- Descendant · 4 generations on · 2 of its ownK162316 Pirouette 014Arravasc, Ltd. · 2016
- Descendant · 4 generations on · 2 of its ownK161427 Pirouette 035Arravasc Limited · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K103464Pacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc. · 2010 · cites it directly9descendants
- K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation · 2014 · 2 generations on6descendants
- K151153Pirouette 018Arravasc Limited · 2015 · 3 generations on4descendants
- K162316Pirouette 014Arravasc, Ltd. · 2016 · 4 generations on2descendants
- K161427Pirouette 035Arravasc Limited · 2016 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042538 | Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model… | Invatec Innovative Technologies | 2004 | — |
| −1 | K062809 | Admiral Xtreme Pta Catheter | Invatec Innovative Technologies | 2006 | — |
| 0 (this device) | K100921 | Admiral Xtreme Pta Balloon Dilatation Catheter | Invatec S.P.A. | 2010 | — |
| +1 | K103464 | Pacific Xtreme Ptca Balloon Dilatation Catheter | Medtronic, Inc. | 2010 | 1 |
| +2 | K133843 | Saber Percutaneous Transluminal Angioplasty Dilatation Catheter | Cordis Corporation | 2014 | 1 |
| +3 | K151153 | Pirouette 018 | Arravasc Limited | 2015 | — |
| +4 | K162316 | Pirouette 014 | Arravasc, Ltd. | 2016 | — |
| +4 | K161427 | Pirouette 035 | Arravasc Limited | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (1)
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 |
|---|---|---|---|
| * | K062809 | Admiral Xtreme Pta CatheterSummary page 1…Common Name: Percutaneous Transluminal Angioplasty Catheter Regulation Name: Percutaneous Catheter Predicate Device Invatec ADMIRAL XTREMETM PTA Catheter (K062809) Device Description The ADMIRAL XTREMETM PTA Balloon Dilatation Catheter is an over-the-wire percutaneous transluminal angiopla… | 2006 |
What descends from it? (12)
See all 123 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 6 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K103464 (Medtronic, Inc., 2010) has gone furthest, with 9 descendants of its own.
- 4 other devices also cite its predicate K062809.
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 ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal 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/K100921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100921: Admiral Xtreme Pta Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100921
Report an extraction error
Are you the manufacturer?
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