510(k) Report

FDA applicant

Lifevac, LLC

Nesconset, NY1 decision2026–20260 recalls

FDA records 1 decision for Lifevac, LLC (Nesconset, NY) in 2026: 1 De Novo grant. All are in product code QXN (Suction Anti-Choking Device As A Second-Line…). 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2026

2026 (partial year): 1
2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

Planning a device like Lifevac, LLC’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?

  • QXNSuction Anti-Choking Device As A Second-Line Treatment1decision

What has FDA decided for it lately?

The one decision as Lifevac, LLC →