510(k) Report

FDA applicant

Puritan-Bennett Ireland, Ltd.

Galway, IE1 decision2000–20002 recalls

FDA records 1 decision for Puritan-Bennett Ireland, Ltd. (Galway, IE) in 2000: 1 510(k) clearance. All are in product code CAF (Nebulizer (Direct Patient Interface)). Its devices cite 2 predicates, 0 of them its own earlier devices. 2 recalls are 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 Puritan-Bennett Ireland, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Puritan-Bennett Ireland, Ltd. since 2007.

Recalls per year

2in 2013

2013: 2
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Puritan-Bennett Ireland, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Puritan-Bennett Ireland, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CAFNebulizer (Direct Patient Interface)1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K990897Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb NebulizerPuritan-Bennett Ireland, Ltd. · 20002cite it

What has FDA decided for it lately?

  • K990897Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb NebulizerPuritan-Bennett Ireland, Ltd. · 20002 recalls

The one decision as Puritan-Bennett Ireland, Ltd. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K964540Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual…Jan 25, 2013Class II
  • K964540Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02…Jan 25, 2013Class II

Other applicant names beginning “Puritan-Bennett”

FDA records each applicant name separately; these may or may not be the same firm.

Puritan Bennett Corp. 114Puritan Medical Products, LLC 8