510(k) Report

510(k) · Cleared

Cleared

VP Sheath

K051580510(k) TraditionalCleared Oct 31, 2005138-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

Flowcardia, Inc. · DQY Catheter, Percutaneous

Cleared on Oct 31, 2005 after a 138-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Oct 31, 2005
Review
138 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
0

5 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2008: 2 descendants cleared2013: 1 descendant cleared2016: 1 descendant cleared2021: 1 descendant cleared20052010201520202025
  1. This deviceK051580 VP SheathFlowcardia, Inc. · 2005
  2. Descendant · cites it directly · 3 of its ownK080849 Microsheath LP and LP-atFlowcardia, Inc. · 2008
  3. Descendant · cites it directly · 3 of its ownK073289 Microsheath XL CathetersFlowcardia, Inc. · 2008
  4. Descendant · 2 generations on · 2 of its ownK131493 Sidekick and Usher Support CathetersC.R. Bard, Inc. · 2013
  5. Descendant · 3 generations on · 1 of its ownK161986 SIDEKICK and USHER Support CathetersBard Peripheral Vascular, Inc. · 2016
  6. Descendant · 3 generations on · 0 of its ownK203275 Recon Support CatheterC.R. Bard, Inc. · 2021

Most influential descendants

Showing 5 of 5 · See all
  • K080849Microsheath LP and LP-atFlowcardia, Inc. · 2008 · cites it directly3descendants
  • K073289Microsheath XL CathetersFlowcardia, Inc. · 2008 · cites it directly3descendants
  • K131493Sidekick and Usher Support CathetersC.R. Bard, Inc. · 2013 · 2 generations on2descendants
  • K161986SIDEKICK and USHER Support CathetersBard Peripheral Vascular, Inc. · 2016 · 3 generations on1descendant
  • K203275Recon Support CatheterC.R. Bard, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K051580VP SheathFlowcardia, Inc.2005—
+1K080849Microsheath LP and LP-atFlowcardia, Inc.2008—
+1K073289Microsheath XL CathetersFlowcardia, Inc.2008—
+2K131493Sidekick and Usher Support CathetersC.R. Bard, Inc.2013—
+3K161986SIDEKICK and USHER Support CathetersBard Peripheral Vascular, Inc.2016—
+3K203275Recon Support CatheterC.R. Bard, Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
201310
201610
202110
FIG. 1 — Lineage of K051580, 2005–2021Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K080849Microsheath LP and LP-atFlowcardia, Inc.20083
K073289Microsheath XL CathetersFlowcardia, Inc.20083

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?

  • Of its descendants, K080849 (Flowcardia, Inc., 2008) has gone furthest, with 3 descendants of its own.

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)—

More from Flowcardia, Inc.

11 FDA decisions under this applicant name. See the company

  • K092175The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200Flowcardia, Inc. · 2010
  • K090621Flowcardia Flowmater Injector, Model Inj 100Flowcardia, Inc. · 2009
  • K091254The Crosser 14 Otw Catheter, Model CRU014Flowcardia, Inc. · 2009
  • K091119Modification to the Crosser SystemFlowcardia, Inc. · 2009
  • K080849Microsheath LP and LP-atFlowcardia, Inc. · 2008

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/K051580 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051580: VP Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051580

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026