Cleared Traditional

K252471 - Paptizer 360 (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252471 · LiViliti Health Products Corporation · General Hospital
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Apr 2026
Decision
266d
Days
Class 2
Risk

K252471 is an FDA 510(k) clearance for the Paptizer 360. Classified as Respiratory Accessory Microbial Reduction Device. (product code QXQ), Class II - Special Controls.

Submitted by LiViliti Health Products Corporation (Lake City, US). The FDA issued a Cleared decision on April 29, 2026 after a review of 266 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6993 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all LiViliti Health Products Corporation devices

Submission Details

510(k) Number K252471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2025
Decision Date April 29, 2026
Days to Decision 266 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 128d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QXQ Respiratory Accessory Microbial Reduction Device.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6993
Definition A Respiratory Accessory Microbial Reduction Device Is A Home-use Device Intended To Be Used As An Adjunct For Microbial Reduction Of Compatible Respiratory Accessories,such As Hoses And Masks,after Cleaning. This Device Is Not Intended To Replace The Original Accessory Manufacturer’s Cleaning Instructions.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Nilo Medical Consulting Group
Michael Nilo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.