510(k) Report

FDA applicant

Velano Vascular

San Francisco, CA8 decisions2015–20221 recall

FDA records 8 decisions for Velano Vascular (San Francisco, CA) from 2015 to 2022: 8 510(k) clearances. Most are in product codes JKA (Tubes, Vials, Systems, Serum Separators, Blood…) and FPA (Set, Administration, Intravascular). Since 2016 its 510(k)s took a median of 128 days from receipt to decision, against 173 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Velano Vascular, Inc.”, “Velano Vascular”.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Velano Vascular’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2015: 12016: 12017: 12019: 22020: 12021: 12022: 1
2015high 2 (2019) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1
2015high 1 (2021) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Velano Vascular by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Velano Vascular’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • JKATubes, Vials, Systems, Serum Separators, Blood Collection6decisions
  • FPASet, Administration, Intravascular2decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 128 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 173 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K200439Velano ExT Extension SetVelano Vascular · 20212cite it
  • K190604PIVOVelano Vascular · 20192cite it
  • K182897Velano Vascular Q2 Extension SetVelano Vascular · 20191cites it
  • K142946TIVAVelano Vascular, Inc. · 20151cites it
  • K152924TIVA¿Velano Vascular · 20161cites it
  • K193569Pivo (TM)Velano Vascular · 20201cites it

What has FDA decided for it lately?

  • K201237Velano Vascular Blood Collection AdapterVelano Vascular · 2022
  • K200439Velano ExT Extension SetVelano Vascular · 2021
  • K193569Pivo (TM)Velano Vascular · 20201 recall
  • K190604PIVOVelano Vascular · 2019
  • K182897Velano Vascular Q2 Extension SetVelano Vascular · 2019
  • K163508PIVOVelano Vascular · 2017
  • K152924TIVA¿Velano Vascular · 2016
  • K142946TIVAVelano Vascular, Inc. · 2015

All 6 as Velano Vascular →The one decision as Velano Vascular, Inc. →The one decision as Velano Vascular →

What has been recalled?

1 recall linked to its devices; the latest:

  • K193569PIVO Blood Collection Device 20G, REF: 202-0005Nov 10, 2021Class II