Cleared Traditional

K221540 - Synexis Sphere Rx

K221540 is an FDA 510(k) clearance for Synexis Sphere Rx, manufactured by Synexis, LLC. The device is a Class 2 General Hospital device with product code FRA cleared through the Traditional 510(k) pathway after a 383-day FDA review.

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

FDA 510(k) Submission Details - K221540

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
254d slower than avg
Panel avg: 129d · This submission: 383d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRA Device Classification - Class 2, Special Controls

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 17
Devices cleared under the same product code (FRA) and FDA review panel - the closest regulatory comparables to K221540.
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