510(k) Report

FDA applicant

Gurunanda, LLC

Buena Park, CA1 decision2023–20230 recalls

FDA records 1 decision for Gurunanda, LLC (Buena Park, CA) in 2023: 1 510(k) clearance. All are in product code LFD (Saliva, Artificial). Its devices cite 1 predicate, 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 Gurunanda, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Gurunanda, LLC by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LFDSaliva, Artificial1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K231205GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral SprayGurunanda, LLC · 2023

The one decision as Gurunanda, LLC →