510(k) · Cleared
ClearedParafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brosmed Medical Co., Ltd. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Feb 27, 2025 as substantially equivalent to K160256 (Brosmed Medical Co., Ltd., 2016) after a 90-day review. Its family tree reaches back 12 generations to 2000.
- Decided
- Feb 27, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K001134 (2000). 27 ancestors in all, the oldest K993305 (2000). No later device cites it as a predicate yet.
- Root · 12 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 8 generations between
- 3 generations backK132777 Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013
- 2 generations backK141118 Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc. · 2014 · Recalled
- 1 generation backK160256 Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2016
- This deviceK243704 Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018…Brosmed Medical Co., Ltd. · 2025
Show all 12 generations
- Root · 12 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
- 11 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
- 10 generations backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
- 9 generations backK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
- 8 generations backK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
- 7 generations backK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
- 6 generations backK093286 Powercross .018 Otw Pta Dilation CatheterEv3, Inc. · 2009 · Recalled
- 5 generations backK123544 Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013
- 4 generations backK130911 Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013
- 3 generations backK132777 Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013
- 2 generations backK141118 Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc. · 2014 · Recalled
- 1 generation backK160256 Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd. · 2016
- This deviceK243704 Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018…Brosmed Medical Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K001134 | Gazelle Balloon Dilatation Catheter | Boston Scientific Corp | 2000 | — |
| −11 | K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Scimed, Inc. | 2002 | 23 |
| −10 | K050389 | Ultra-Soft SV Balloon Dilatation Catheter | Boston Scientific Corp | 2005 | — |
| −9 | K053116 | Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx | Boston Scientific Corp | 2005 | — |
| −8 | K072283 | Dorado Pta Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2007 | 15 |
| −7 | K082579 | Evercross .035 Otw Pta Dilatation Catheter | Ev3, Inc. | 2008 | 1 |
| −6 | K093286 | Powercross .018 Otw Pta Dilation Catheter | Ev3, Inc. | 2009 | 2 |
| −5 | K123544 | Rapidcross Pta Rapid Exchange, Balloon Dilatation Catheter | Ev3, Inc. | 2013 | — |
| −4 | K130911 | Rapidcross Pta Rapid Exchange Balloon Dilatation Catheter | Ev3, Inc. | 2013 | — |
| −3 | K132777 | Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation Catheter | Ev3, Inc. | 2013 | — |
| −2 | K141118 | Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation Catheter | Ev3, Inc. | 2014 | 1 |
| −1 | K160256 | Polux , Minerva and Atropos PTA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2016 | — |
| 0 (this device) | K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon… | Brosmed Medical Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K160256 | Polux , Minerva and Atropos PTA Balloon Dilatation CatheterSummary page 5…anel: Cardiovascular 3. PREDICATE DEVICE AND REFERENCE DEVICES Primary Predicate Device: Polux, Minerva, Atropos PTA Balloon Catheter (K160256, cleared on July 29, 2016) Reference Devices: Ultraverse 014 and 018 PTA Balloon Dilatation Catheters (K192318, clea… | 2016 |
| † | K192318 | Ultraverse 014 and 018 PTA Balloon Dilatation Catheters | 2019 |
| † | K121856 | Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line Extension | 2012 |
| † | K093965 | Ultraverse 014 and 018 Balloon Dilatation Catheters | 2010 |
| † | K142261 | Ultraverse 035 PTA Balloon Dilatation Catheter | 2014 |
| † | K102035 | Sleek Otw Pta Catheters | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 27 ancestors have a recall of any class.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Parafleet SC 014 / Parafleet SC 018 / Parafleet SC 035 is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243704: Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 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/K243704
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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