Cleared Traditional

Synexis Sphere Rx

K221540 · Synexis, LLC · General Hospital
Jun 2023
Decision
383d
Days
Class 2
Risk

About This 510(k) Submission

K221540 is an FDA 510(k) clearance for the Synexis Sphere Rx, a Purifier, Air, Ultraviolet, Medical (Class II — Special Controls, product code FRA), submitted by Synexis, LLC (Lenexa, US). The FDA issued a Cleared decision on June 14, 2023, 383 days after receiving the submission on May 27, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6500.

Submission Details

510(k) Number K221540 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2022
Decision Date June 14, 2023
Days to Decision 383 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRA — Purifier, Air, Ultraviolet, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6500