510(k) Report

510(k) · Cleared

Cleared

Occlusion Balloon Catheter

K070126510(k) TraditionalCleared Feb 8, 2008388-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

Sentreheart, Inc. · DQY Catheter, Percutaneous

Cleared on Feb 8, 2008 as substantially equivalent to K032869 (Cook, Inc., 2003) and 2 other predicates after a 388-day review. Its family tree reaches back 2 generations to 1979.

Decided
Feb 8, 2008
Review
388 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K781772 (1979). 12 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2002: 1 other ancestor2001: 2 other ancestors1996: 2 other ancestors1995: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor1992: 1 other ancestorK781772 · Catheter, Transluminal Balloon · Medi-Tech, Inc. · 1979K993292 · Boston Scientific/Target Sentry Occlusion Balloon Catheter · Boston Scientific, Target · 200019751980198519901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 8 other ancestors K993292 · Boston Scientific/Target Sentry Occlusion Balloon Catheter · Boston Scientific, Target · 2000K781772 · Catheter, Transluminal Balloon · Medi-Tech, Inc. · 19790
  1. Root · 2 generations backK781772 Catheter, Transluminal BalloonMedi-Tech, Inc. · 1979
  2. 1 generation backK993292 Boston Scientific/Target Sentry Occlusion Balloon CatheterBoston Scientific, Target · 2000
  3. This deviceK070126 Occlusion Balloon CatheterSentreheart, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K781772Catheter, Transluminal BalloonMedi-Tech, Inc.1979—
−1K993292Boston Scientific/Target Sentry Occlusion Balloon CatheterBoston Scientific, Target2000—
0 (this device)K070126Occlusion Balloon CatheterSentreheart, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199310
199410
199510
199620
200120
200210
200310
FIG. 1 — Lineage of K070126, 1979–2008Source: 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? (3)

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
*K032869Cook Coda Balloon Catheter
Summary page 2
…510(k) Notification SECTION 4 - 510(K) SUMMARY Predicate Devices: CODA Balloon Catheter, Cook Corp (K032869) Equalizer Balloon Catheter, Boston Scientific (K021721) Sentry Balloon Catheter, Boston Scientific (993292) Safety and Performa…
Cook, Inc.2003—
*K021721Equalizer Balloon Catheter
Summary page 2
…SECTION 4 - 510(K) SUMMARY Predicate Devices: CODA Balloon Catheter, Cook Corp (K032869) Equalizer Balloon Catheter, Boston Scientific (K021721) Sentry Balloon Catheter, Boston Scientific (993292) Safety and Performance: Performance Functional testing was conducted to sup…
Boston Scientific Corp20024
*K993292Boston Scientific/Target Sentry Occlusion Balloon Catheter
Summary page 2
…UMMARY Predicate Devices: CODA Balloon Catheter, Cook Corp (K032869) Equalizer Balloon Catheter, Boston Scientific (K021721) Sentry Balloon Catheter, Boston Scientific (993292) Safety and Performance: Performance Functional testing was conducted to support the claim of substantial equivalence and to dem…
Boston Scientific, Target2000—

Also cleared against K032869: 8 other devices →

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 29 years and passes through 3 companies; a new generation was cleared every 21.0 years on median.
  • 1 of the 12 ancestors has a recall of any class.
  • 8 other devices also cite its predicate K032869.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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 SentreHeart Occlusion Balloon Catheter is intended for temporary occlusion of large vessels in applications such as arteriography, preoperative occlusion, and emergency controlled hemorrhage procedures.

Indications for use as stated in the FDA summary.

Also cleared against K032869

8 other devices cite the same predicate.

  • K151821ER-REBOA CatheterPryor Medical Devices, Inc. · 2015
  • K150970Coda LP Balloon CatheterCook Incorporated · 2015
  • K122917Coda Balloon CatheterCook, Inc. · 2013
  • K110891The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2011
  • K101877Occlusion Balloon Catheter Model ObcCook, Inc. · 2010
  • K091624Stent Graft Balloon CatheterVia Biomedical, Inc. · 2009

More from Sentreheart, Inc.

5 FDA decisions under this applicant name. See the company

  • K153096LARIAT RS Suture Delivery DeviceSentreheart, Inc. · 2015
  • K142241LARIAT sulture Delivery DeviceSentreheart, Inc. · 2014
  • K090385Lariat II Suture Delivery DeviceSentreheart, Inc. · 2009
  • K080364Findrwirz Guide Wire SystemSentreheart, Inc. · 20081 Class I recall

Recent decisions in DQY

The DQY category page

  • K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. · 2026
  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K070126 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070126: Occlusion Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070126

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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