510(k) Report

FDA applicant

Nellcor Puritan Bennett France Dvpt.

Villers-Les-Nancy Cedex, FR2 decisions1999–20000 recalls

FDA records 2 decisions for Nellcor Puritan Bennett France Dvpt. (Villers-Les-Nancy Cedex, FR) from 1999 to 2000: 2 510(k) clearances. All are in product code BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 2 predicates, 1 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 France Dvpt.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nellcor Puritan Bennett France Dvpt. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Nellcor Puritan Bennett France Dvpt.’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.