510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980109Substantially Equivalent

Cyclotech Cyclosporine Oral Solutions Dispenser

Sangstat Medical Corp., Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980109 is the FDA 510(k) clearance record for CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER, a class I device, cleared for Sangstat Medical Corp. on under FDA product code KYX (Dispenser, Liquid Medication). FDA records list 3 510(k) clearances for Sangstat Medical Corp., from to . As of , FDA records show no recalls naming K980109.

Clearance record

Decision date
Received
(218 days to decision)
Product code
KYX Dispenser, Liquid Medication
Regulation
21 CFR 880.6430
Device class
Class I
Review panel
General Hospital
Applicant
Sangstat Medical Corp. 6300 Dumbarton Cir., Fremont CA
510(k) summary
Summary
Third party review
No

Clearances, product code KYX

Trailing 12 months

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

FDA records show no clearances under product code KYX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KYX, 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