510(k) Report

510(k) · Cleared

Cleared

Ultra-Soft SV Balloon Dilatation Catheter

K050389510(k) TraditionalCleared May 25, 200599-day reviewClass II21 CFR 870.1250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific Corp · DQY Catheter, Percutaneous

Cleared on May 25, 2005 as substantially equivalent to K021735 (Boston Scientific Scimed, Inc., 2002) after a 99-day review. Its family tree reaches back 2 generations to 2000. 164 later devices descend from it.

Decided
May 25, 2005
Review
99 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K001134 (2000). 164 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2011: 12 descendants cleared2008: 5 descendants cleared2009: 3 descendants cleared2013: 9 descendants cleared2007: 3 descendants cleared2012: 14 descendants cleared2016: 12 descendants cleared2014: 13 descendants cleared2015: 13 descendants cleared2025: 7 descendants cleared2010: 4 descendants cleared2022: 12 descendants cleared2018: 6 descendants cleared2024: 12 descendants cleared2026: 8 descendants cleared2019: 5 descendants cleared2017: 7 descendants cleared2020: 10 descendants cleared2023: 3 descendants cleared2021: 4 descendants clearedK001134 · Gazelle Balloon Dilatation Catheter · Boston Scientific Corp · 2000K021735 · Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter · Boston Scientific Scimed, Inc. · 2002 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 17 descendants3 generations forward: 31 descendants4 generations forward: 50 descendants5 generations forward: 24 descendants6 generations forward: 17 descendants7 generations forward: 11 descendants8 generations forward: 9 descendants9 generations forward: 2 descendants K021735 · Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter · Boston Scientific Scimed, Inc. · 2002 · recalledK001134 · Gazelle Balloon Dilatation Catheter · Boston Scientific Corp · 20000+5
  1. Root · 2 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
  2. 1 generation backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
  3. This deviceK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
  4. Descendant · cites it directly · 133 of its ownK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
  5. Descendant · 2 generations on · 96 of its ownK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
  6. Descendant · cites it directly · 62 of its ownK053118 Sterling Monorail Pta Balloon Dilatation Catheter, Model…Boston Scientific Corp · 2005
  7. Descendant · 3 generations on · 44 of its ownK083657 Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled
  8. Descendant · 3 generations on · 36 of its ownK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010

Showing 5 of 164 descendants. See all descendants

Descendants cleared per year

2005: 22007: 32008: 52009: 32010: 42011: 122012: 142013: 92014: 132015: 132016: 122017: 72018: 62019: 52020: 102021: 42022: 122023: 32024: 122025: 72026: 8
2005high 14 (2012) · low 0 (2006)2026

Most influential descendants

Showing 5 of 164 · See all
  • K053116Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005 · cites it directly133descendants
  • K072283Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · 2 generations on96descendants
  • K053118Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-XxxxxxBoston Scientific Corp · 2005 · cites it directly62descendants
  • K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · 3 generations on44descendants
  • K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010 · 3 generations on36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K001134Gazelle Balloon Dilatation CatheterBoston Scientific Corp2000—
−1K021735Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc.200223
0 (this device)K050389Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp2005—
+1K053116Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp2005—
+2K072283Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc.200715
+1K053118Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-XxxxxxBoston Scientific Corp2005—
+3K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc.20082
+3K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200730
200850
200930
201040
2011120
2012140
201390
2014130
2015130
2016120
201770
201860
201950
2020100
202140
2022120
202330
2024120
202570
202680
FIG. 1 — Lineage of K050389, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K021735Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter
Summary page 1
…Dilatation Catheter Predicate Device Boston Scientific Corporation Ultrasoft TM SV Balloon Dilatation Catheter (K021735; cleared August 8, 2002) Device Description TM…
Boston Scientific Scimed, Inc.200223

Also cleared against K021735: 2 other devices →

What descends from it? (164)

See all 164

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K053116Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp2005133
K053118Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-XxxxxxBoston Scientific Corp200562
K112513Ebony Pta 0.014 Peripheral Dilatation CatheterNatec Medical, Ltd.20113

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 5 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K053116 (Boston Scientific Corp, 2005) has gone furthest, with 133 descendants of its own.
  • 2 other devices also cite its predicate K021735.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

The Ultra-soft TM SV Balloon Dilatation Catheters are indicated for percutaneous transluminal angioplasty (PTA) of the carotid, iliac, femoral, ilio-femoral, 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.

Also cleared against K021735

2 other devices cite the same predicate.

  • K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary…Boston Scientific Corporation · 2016
  • K053116Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005

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https://510kreport.com/device/K050389 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050389: Ultra-Soft SV Balloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050389

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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