510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K894072Substantially Equivalent

The Pudenz in Line Valve

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

K894072 is the FDA 510(k) clearance record for THE PUDENZ IN LINE VALVE, 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 no recalls naming K894072.

Clearance record

Decision date
Received
(60 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 7280 N. Caldwell, Niles IL
Third party review
No

Clearances, product code JXG

Trailing 12 months
3 clearances under product code JXG in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JXG, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20261
November 20260