Paptizer 360— 510(k) K252471

Name: FDA 510(k) clearance K252471
Creator: U.S. Food and Drug Administration
Published: 2026-04-29

Substantially Equivalent

LiViliti Health Products Corporation

FDA 510(k) clearance K252471 for Paptizer 360, Substantially Equivalent on 2026-04-29. Applicant: LiViliti Health Products Corporation. Device class: 2.

Summary

Paptizer 360 comes from LiViliti Health Products and is filed under product code QXQ (Respiratory Accessory Microbial Reduction Device).

Class II, 21 CFR 880.6993. It came in as a Traditional 510(k), and General Hospital is both the classification panel and the review panel.

LiViliti filed from Lake City, Florida. Review took 266 calendar days (August 6, 2025 to April 29, 2026).

Clearance details

Applicant: LiViliti Health Products Corporation
Product code: Product code QXQ
Device class: Class 2
Regulation: 21 CFR 880.6993
Advisory panel: General Hospital
Date received: 2025-08-06
Decision date: 2026-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake City, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.