510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K163316Substantially Equivalent

Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System

CareFusion 303, Inc, Vernon Hills IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163316 is the FDA 510(k) clearance record for Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System, a class II device, cleared for Carefusion 303, Inc. on under FDA product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)). FDA records list 26 510(k) clearances for Carefusion 303, Inc., from to . As of , FDA records show no recalls naming K163316.

Clearance record

Decision date
Received
(211 days to decision)
Product code
DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Regulation
21 CFR 870.2900
Device class
Class II
Review panel
Cardiovascular
Applicant
Carefusion 303, Inc. 75 N Fairway Dr., Vernon Hills IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DSA

Trailing 12 months
2 clearances under product code DSA in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260