FDA applicant

Nellcor Puritan Bennett (Melville), Ltd.

Kanata, Ontario, CA1 decision2003–20030 recalls

FDA records 1 decision for Nellcor Puritan Bennett (Melville), Ltd. (Kanata, Ontario, CA) in 2003: 1 510(k) clearance. All are in product code MNR (Ventilatory Effort Recorder). Its devices cite 2 predicates, 0 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, anesthesiology panel, where it files most

How often FDA has decided Nellcor Puritan Bennett (Melville), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nellcor Puritan Bennett (Melville), Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Nellcor Puritan Bennett (Melville), 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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Other applicant names beginning “Nellcor”

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

Nellcor Puritan Bennett, Inc. 44 Nellcor, Inc. 18 Nellcor Puritan Bennett France Dvpt. 2

Nellcor Puritan Bennett (Melville), Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Nellcor”