510(k) Report

FDA applicant

Ivera Medical, Inc.

Carlsbad, CA4 decisions2011–20140 recalls

FDA records 4 decisions for Ivera Medical, Inc. (Carlsbad, CA) from 2011 to 2014: 4 510(k) clearances. All are in product code QBP (Cap, Device Disinfectant). Its devices cite 8 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Ivera Medical”.

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 Ivera Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 12012: 22014: 1
2011high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Ivera Medical, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ivera Medical, 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?

  • QBPCap, Device Disinfectant4decisions

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 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.

  • K111992Curos Port ProtectorIvera Medical, Inc. · 20125cite it
  • K110826Curos Port ProtectorIvera Medical · 20111cites it

What has FDA decided for it lately?

  • K140657Curos Red Port ProtectorIvera Medical, Inc. · 2014
  • K121171Curos TipIvera Medical, Inc. · 2012
  • K111992Curos Port ProtectorIvera Medical, Inc. · 2012
  • K110826Curos Port ProtectorIvera Medical · 2011

All 3 as Ivera Medical, Inc. →The one decision as Ivera Medical →