FDA applicant

Glaxosmithkline Consumer Healthcare

Parsippany, NJ4 decisions2004–20100 recalls

FDA records 4 decisions for Glaxosmithkline Consumer Healthcare (Parsippany, NJ) from 2004 to 2010: 4 510(k) clearances. Most are in product codes ONT (N95 Respirator With Antimicrobial/Antiviral…) and ORW (N95 Respirator With Antimicrobial/Antiviral…). Its devices cite 7 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Glaxosmithkline Consumer Healthcare, L.P.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

2in 2010

2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Glaxosmithkline Consumer Healthcare’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 “Glaxosmithkline”

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

Glaxosmithkline Consumer Healthcare (Gskch) 3

Glaxosmithkline Consumer Healthcare

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Glaxosmithkline”