510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K904883Substantially Equivalent

Optyx

Baxter Healthcare Corporation, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904883 is the FDA 510(k) clearance record for OPTYX, a class II device, cleared for Baxter Healthcare Corp on under FDA product code JXG (Shunt, Central Nervous System And Components). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show one recall naming K904883.

Clearance record

Decision date
Received
(271 days to decision)
Product code
JXG Shunt, Central Nervous System And Components
Regulation
21 CFR 882.5550
Device class
Class II
Review panel
Neurology
Applicant
Baxter Healthcare Corp 17221 Red Hill Ave., Irvine CA
Third party review
No

Clearances, product code JXG

Trailing 12 months
5 clearances under product code JXG in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JXG, trailing twelve months
MonthClearances
November 20252
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20261