510(k) Report

FDA applicant

Renovorx, Inc.

Los Altos, CA4 decisions2014–20211 recall

FDA records 4 decisions for Renovorx, Inc. (Los Altos, CA) from 2014 to 2021: 4 510(k) clearances. All are in product code MJN (Catheter, Intravascular Occluding, Temporary). Since 2016 its 510(k)s took a median of 51 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2021

2014: 12017: 12019: 12021: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2014high 1 (2015) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Renovorx, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Renovorx, Inc.’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?

  • MJNCatheter, Intravascular Occluding, Temporary4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 51 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 116 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K191606RenovoCathRenovorx, Inc. · 20191cites it
  • K160067RenovoCathRenovorx, Inc. · 20171cites it

What has FDA decided for it lately?

  • K212324RenovoCathRenovorx, Inc. · 2021
  • K191606RenovoCathRenovorx, Inc. · 2019
  • K160067RenovoCathRenovorx, Inc. · 2017
  • K141175Renovocath RC120Renovorx, Inc. · 20141 recall

All 4 as Renovorx, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K141175RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number…Nov 25, 2015Class II