510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K940648Substantially Equivalent

Cordis Disposable Icp Pressure Transducer

Cordis US Corp., Miami Lakes FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940648 is the FDA 510(k) clearance record for CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER, a class II device, cleared for Cordis Corp. on under FDA product code GWM (Device, Monitoring, Intracranial Pressure). FDA records list 332 510(k) clearances for Cordis US Corp., from to . As of , FDA records show no recalls naming K940648.

Clearance record

Decision date
Received
(379 days to decision)
Product code
GWM Device, Monitoring, Intracranial Pressure
Regulation
21 CFR 882.1620
Device class
Class II
Review panel
Neurology
Applicant
Cordis Corp. 14201 NW 60th Ave., Miami Lakes FL
510(k) summary
Summary
Third party review
No

Clearances, product code GWM

Trailing 12 months
1 clearance under product code GWM in the twelve months to November 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GWM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260