510(k) Report

FDA applicant

Pharmacaribe

Bonita Springs, FL4 decisions2009–20131 recall

FDA records 4 decisions for Pharmacaribe (Bonita Springs, FL) from 2009 to 2013: 4 510(k) clearances. Most are in product codes NVO (Spacer, Direct Patient Interface) and CAF (Nebulizer (Direct Patient Interface)). Its devices cite 7 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2013

2009: 12010: 22013: 1
2009high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2009high 1 (2015) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Pharmacaribe by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pharmacaribe’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?

  • NVOSpacer, Direct Patient Interface2decisions
  • CAFNebulizer (Direct Patient Interface)2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K101424Pharmacaribe Inhaled Saline SolutionsPharmacaribe · 20104cite it
  • K091862Nessi SpacerPharmacaribe · 20091cites it

What has FDA decided for it lately?

  • K130091PulmosalPharmacaribe · 20131 recall
  • K101532Nessi Otc SpacerPharmacaribe · 2010
  • K101424Pharmacaribe Inhaled Saline SolutionsPharmacaribe · 2010
  • K091862Nessi SpacerPharmacaribe · 2009

All 4 as Pharmacaribe →

What has been recalled?

1 recall linked to its devices; the latest:

  • K130091PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative…Dec 29, 2015Class II