Cleared Traditional

K221540 - Synexis Sphere Rx (FDA 510(k) Clearance)

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

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

K221540 is an FDA 510(k) clearance for the Synexis Sphere Rx. Classified as Purifier, Air, Ultraviolet, Medical (product code FRA), Class II - Special Controls.

Submitted by Synexis, LLC (Lenexa, US). The FDA issued a Cleared decision on June 14, 2023 after a review of 383 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6500 - 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. Elevated predicate reliance profile. 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 Synexis, LLC devices

Submission Details

510(k) Number K221540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
255d slower than avg
Panel avg: 128d · This submission: 383d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRA Purifier, Air, Ultraviolet, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6500
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 Peers - FRA Purifier, Air, Ultraviolet, Medical

All 35
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