510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221540Substantially Equivalent

Synexis Sphere Rx

Synexis, LLC, Lenexa KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221540 is the FDA 510(k) clearance record for Synexis Sphere Rx, a class II device, cleared for Synexis, LLC on under FDA product code FRA (Purifier, Air, Ultraviolet, Medical). FDA records list one 510(k) clearance for Synexis, LLC. As of , FDA records show no recalls naming K221540.

Clearance record

Decision date
Received
(383 days to decision)
Product code
FRA Purifier, Air, Ultraviolet, Medical
Regulation
21 CFR 880.6500
Device class
Class II
Review panel
General Hospital
Applicant
Synexis, LLC 11711 W. 79th St., Lenexa KS
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRA

Trailing 12 months

FDA records hold no clearances under product code FRA in the trailing twelve months.

FDA records show no clearances under product code FRA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FRA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260