510(k) · Cleared
ClearedRapidcross Pta Rapid Exchange, Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ev3, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Feb 12, 2013 as substantially equivalent to K082854 (Ev3, Inc., 2008) and 4 other predicates after an 85-day review. Its family tree reaches back 7 generations to 2000. 8 later devices descend from it.
- Decided
- Feb 12, 2013
- Review
- 85 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K001134 (2000). 19 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 6 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 5 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 4 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 3 generations backK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
- 2 generations backK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
- 1 generation backK093286 Powercross .018 Otw Pta Dilation CatheterEv3, Inc. · 2009 · Recalled
- This deviceK123544 Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013
- Descendant · cites it directly · 7 of its ownK130911 Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013
- Descendant · 2 generations on · 6 of its ownK132777 Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013
- Descendant · 3 generations on · 5 of its ownK141118 Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 1 of its ownK160256 Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK142459 Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd. · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013 · cites it directly7descendants
- K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013 · 2 generations on6descendants
- K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc. · 2014 · 3 generations on5descendants
- K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2016 · 4 generations on1descendant
- K142459Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd. · 2015 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −6 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −5 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −4 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −3 | K072283 | Dorado Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2007 | 15 |
| −2 | K082579 | Evercross .035 Otw Pta Dilatation Catheter | Ev3, Inc. | 2008 | 1 |
| −1 | K093286 | Powercross .018 Otw Pta Dilation Catheter | Ev3, Inc. | 2009 | 2 |
| 0 (this device) | K123544 | Rapidcross Pta Rapid Exchange, Balloon Dilatation Catheter | Ev3, Inc. | 2013 | — |
| +1 | K130911 | Rapidcross Pta Rapid Exchange Balloon Dilatation Catheter | Ev3, Inc. | 2013 | — |
| +2 | K132777 | Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation Catheter | Ev3, Inc. | 2013 | — |
| +3 | K141118 | Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation Catheter | Ev3, Inc. | 2014 | 1 |
| +4 | K160256 | Polux , Minerva and Atropos PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2016 | — |
| +1 | K142459 | Ebony PTA 0.014 RX Peripheral Dilatation Catheter | Natec Medical, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 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 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? (5)
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 |
|---|---|---|---|
| * | K082854 | Nanocorss .014 Otw Pta Dilatation CatheterSummary page 1…DQY) Classification Panel Cardiovascular Predicate Devices NamoCrossTM .0 14 OTW PTA Dilatation Catheter (K082854, K090849), PowerCross TM .0 18 OTW PTA Dilatation Catheter… | 2008 |
| * | K090849 | Modification to: Nanocross 0.14 Otw Pta Dilatation Catheter, Models AB14W020210090…Summary page 1…diovascular Predicate Devices NamoCrossTM .0 14 OTW PTA Dilatation Catheter (K082854, K090849), PowerCross TM .0 18 OTW PTA Dilatation Catheter (K093286), Sterling T M Mono… | 2009 |
| * | K093286 | Powercross .018 Otw Pta Dilation CatheterSummary page 1…K082854, K090849), PowerCross TM .0 18 OTW PTA Dilatation Catheter (K093286), Sterling T M MonorailTM PTA Balloon Dilatation Catheter (K053 118), and Adva… | 2009 |
| * | K053118 | Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-XxxxxxSummary page 1…(K093286), Sterling T M MonorailTM PTA Balloon Dilatation Catheter (K053 118), and Advance® 14LP Low Profile PTA Balloon Dilatation Catheters (K090822).… | 2005 |
| * | K090822 | Advance 14RX Rapid Exchange Pta Balloon CatheterSummary page 1…Catheter (K053 118), and Advance® 14LP Low Profile PTA Balloon Dilatation Catheters (K090822). Intended use The RaiidCroSSTM PTA Rapid Exchange Balloon Dilatation… | 2009 |
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 13 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 19 ancestors have a recall of any class.
- Of its descendants, K130911 (Ev3, Inc., 2013) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K082854.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 RapidCross™ PTA Rapid Exchange 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/K123544 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123544: Rapidcross Pta Rapid Exchange, Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123544
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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