510(k) Report

510(k) · Cleared

Cleared

Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx

K053116510(k) TraditionalCleared Dec 16, 200539-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 Dec 16, 2005 as substantially equivalent to K021735 (Boston Scientific Scimed, Inc., 2002) and 1 other predicate after a 39-day review. Its family tree reaches back 3 generations to 2000. 133 later devices descend from it.

Decided
Dec 16, 2005
Review
39 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K001134 (2000). 133 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2008: 4 descendants cleared2009: 3 descendants cleared2013: 9 descendants cleared2007: 1 descendant cleared2025: 7 descendants cleared2010: 3 descendants cleared2011: 10 descendants cleared2012: 8 descendants cleared2015: 9 descendants cleared2016: 10 descendants cleared2014: 11 descendants cleared2018: 6 descendants cleared2019: 4 descendants cleared2017: 6 descendants cleared2022: 9 descendants cleared2020: 9 descendants cleared2023: 3 descendants cleared2024: 12 descendants cleared2026: 6 descendants cleared2021: 3 descendants clearedK001134 · Gazelle Balloon Dilatation Catheter · Boston Scientific Corp · 2000K021735 · Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter · Boston Scientific Scimed, Inc. · 2002 · recalledK050389 · Ultra-Soft SV Balloon Dilatation Catheter · Boston Scientific Corp · 2005200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 23 descendants3 generations forward: 45 descendants4 generations forward: 27 descendants5 generations forward: 17 descendants6 generations forward: 8 descendants7 generations forward: 6 descendants8 generations forward: 1 descendant K050389 · Ultra-Soft SV Balloon Dilatation Catheter · Boston Scientific Corp · 2005K021735 · 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 · 3 generations backK001134 Gazelle Balloon Dilatation CatheterBoston Scientific Corp · 2000
  2. 2 generations backK021735 Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc. · 2002 · Recalled
  3. 1 generation backK050389 Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005
  4. This deviceK053116 Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp · 2005
  5. Descendant · cites it directly · 96 of its ownK072283 Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · Recalled
  6. Descendant · 2 generations on · 44 of its ownK083657 Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · Recalled
  7. Descendant · 2 generations on · 36 of its ownK103459 Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010
  8. Descendant · cites it directly · 35 of its ownK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
  9. Descendant · cites it directly · 35 of its ownK080982 Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation…Boston Scientific Corp · 2008

Showing 5 of 133 descendants. See all descendants

Descendants cleared per year

2007: 12008: 42009: 32010: 32011: 102012: 82013: 92014: 112015: 92016: 102017: 62018: 62019: 42020: 92021: 32022: 92023: 32024: 122025: 72026: 6
2007high 12 (2024) · low 1 (2007)2026

Most influential descendants

Showing 5 of 133 · See all
  • K072283Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2007 · cites it directly96descendants
  • K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc. · 2008 · 2 generations on44descendants
  • K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc. · 2010 · 2 generations on36descendants
  • K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · cites it directly35descendants
  • K080982Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation CathetersBoston Scientific Corp · 2008 · cites it directly35descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K001134Gazelle Balloon Dilatation CatheterBoston Scientific Corp2000—
−2K021735Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc.200223
−1K050389Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp2005—
0 (this device)K053116Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp2005—
+1K072283Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc.200715
+2K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc.20082
+2K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc.2010—
+1K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc.20081
+1K080982Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation CathetersBoston Scientific Corp2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200840
200930
201030
2011100
201280
201390
2014110
201590
2016100
201760
201860
201940
202090
202130
202290
202330
2024120
202570
202660
FIG. 1 — Lineage of K053116, 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? (2)

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
…PTA Balloon Dilatation Catheter Product Code DQY Classification of Class II, 21 CFR Part 870.1250 Device Predicate Device Ultra-softTM SV K021735 August 8, 2002 Balloon Dilatation Catheter Ult…
Boston Scientific Scimed, Inc.200223
*K050389Ultra-Soft SV Balloon Dilatation Catheter
Summary page 1
…SV K021735 August 8, 2002 Balloon Dilatation Catheter Ultra-softTM SV K050389 May 25, 2005 Balloon Dilatation Catheter Device The Sterli…
Boston Scientific Corp2005—

Also cleared against K021735: 2 other devices →

What descends from it? (133)

See all 133

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

NumberDeviceApplicantDecidedDescendants
K072283Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc.200796
K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc.200835
K080982Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation CathetersBoston Scientific Corp200835
K093720Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon…Boston Scientific Corp200921
K132430Sterling Over-the-Wire (Otw) Pta Balloon Dilatation CatheterBoston Scientific Corp201319
K083139Vipersphere Pta Balloon CatheterCardiovascular Systems, Inc.20080

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 1.9 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K072283 (Bard Peripheral Vascular, Inc., 2007) has gone furthest, with 96 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 Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

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
  • K050389Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp · 2005

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https://510kreport.com/device/K053116 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053116: Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053116

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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