FDA applicant

Nellcor, Inc.

Hayward, CA18 decisions1982–19952 recalls

FDA records 18 decisions for Nellcor, Inc. (Hayward, CA) from 1982 to 1995: 18 510(k) clearances. Most are in product codes DQA (Oximeter) and DXN (System, Measurement, Blood-Pressure…). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Nellcor, Inc. since 2007.

Recalls per year

1in 2016

2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

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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 Puritan Bennett France Dvpt. 2 Nellcor Puritan Bennett (Melville), Ltd. 1

Nellcor, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Nellcor”