510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231664Substantially Equivalent

IRRAflow Active Fluid Exchange System (AFES)

Irras USA, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231664 is the FDA 510(k) clearance record for IRRAflow Active Fluid Exchange System (AFES), a class II device, cleared for Irras USA, Inc. on under FDA product code JXG (Shunt, Central Nervous System And Components). FDA records list 4 510(k) clearances for Irras USA, Inc., from to . As of , FDA records show no recalls naming K231664.

Clearance record

Decision date
Received
(134 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
Irras USA, Inc. 11975 El Camino Real, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JXG

Trailing 12 months
4 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 20260