510(k) Report

FDA applicant

Corindus, Inc.

Waltham, MA9 decisions2012–20220 recalls

FDA records 9 decisions for Corindus, Inc. (Waltham, MA) from 2012 to 2022: 9 510(k) clearances. All are in product code DXX (System, Catheter Control, Steerable). Since 2016 its 510(k)s took a median of 76 days from receipt to decision, against 76 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 11 of them its own earlier devices. No 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 Corindus, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2012: 12015: 12016: 22018: 32020: 12022: 1
2012high 3 (2018) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Corindus, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Corindus, 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?

  • DXXSystem, Catheter Control, Steerable9decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 76 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 76 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 15 predicates; 11 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.

  • K120834Corpath 200 SystemCorindus, Inc. · 20123cite it
  • K160121CorPath GRX SystemCorindus, Inc. · 20162cite it
  • K150892CorPath 200 SystemCorindus, Inc. · 20152cite it
  • K202275CorPath GRX SystemCorindus, Inc. · 20201cites it
  • K173806CorPath GRX SystemCorindus, Inc. · 20181cites it
  • K173288CorPath GRX SystemCorindus, Inc. · 20181cites it

What has FDA decided for it lately?

  • K221464CorPath GRX SystemCorindus, Inc. · 2022
  • K202275CorPath GRX SystemCorindus, Inc. · 2020
  • K180517CorPath GRX SystemCorindus, Inc. · 2018
  • K173806CorPath GRX SystemCorindus, Inc. · 2018
  • K173288CorPath GRX SystemCorindus, Inc. · 2018
  • K160121CorPath GRX SystemCorindus, Inc. · 2016
  • K152999CorPath 200 SystemCorindus, Inc. · 2016
  • K150892CorPath 200 SystemCorindus, Inc. · 2015

All 9 as Corindus, Inc. →