510(k) Report

FDA applicant

J & J Solutions, Inc. D/B/A/ Corvida Medical

Eagan, MN2 decisions2015–20181 recall

FDA records 2 decisions for J & J Solutions, Inc. D/B/A/ Corvida Medical (Eagan, MN) from 2015 to 2018: 2 510(k) clearances. All are in product code ONB (Closed Antineoplastic And Hazardous Drug…). Its devices cite 4 predicates, 1 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, general hospital panel, where it files most

How often FDA has decided J & J Solutions, Inc. D/B/A/ Corvida Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2015: 12018: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2015high 1 (2016) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — J & J Solutions, Inc. D/B/A/ Corvida Medical by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like J & J Solutions, Inc. D/B/A/ Corvida…’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?

  • ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 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.

  • K150486HaloJ & J Solutions, Inc. D/B/A/ Corvida Medical · 20151cites it

What has FDA decided for it lately?

  • K180574Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe…J & J Solutions, Inc. D/B/A/ Corvida Medical · 2018
  • K150486HaloJ & J Solutions, Inc. D/B/A/ Corvida Medical · 20151 recall

All 2 as J & J Solutions, Inc. D/B/A/ Corvida Medical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K150486Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only…Nov 22, 2016Class II