510(k) Report

FDA applicant

Parnell Pharmaceuticals, Inc.

San Rafael, CA1 decision2006–20060 recalls

FDA records 1 decision for Parnell Pharmaceuticals, Inc. (San Rafael, CA) in 2006: 1 510(k) clearance. All are in product code LFD (Saliva, Artificial). Its devices cite 5 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

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

FDA decisions per year

No FDA decision for Parnell Pharmaceuticals, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Parnell Pharmaceuticals, Inc.’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?

  • LFDSaliva, Artificial1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K062653Mouthkote Oral Moisturizer, Model 50930-098Parnell Pharmaceuticals, Inc. · 20061cites it

What has FDA decided for it lately?

  • K062653Mouthkote Oral Moisturizer, Model 50930-098Parnell Pharmaceuticals, Inc. · 2006

The one decision as Parnell Pharmaceuticals, Inc. →