510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K002739Substantially Equivalent

Infusor Patient Control Module, 2Ml, Model 2C1067k

Baxter Healthcare Corporation, Round Lake IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K002739 is the FDA 510(k) clearance record for INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K, a class II device, cleared for Baxter Healthcare Corp on under FDA product code MEA (Pump, Infusion, Pca). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K002739.

Clearance record

Decision date
Received
(10 days to decision)
Product code
MEA Pump, Infusion, Pca
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Baxter Healthcare Corp Rt. 120 & Wilson Rd., Round Lake IL
510(k) summary
Summary
Third party review
No

Clearances, product code MEA

Trailing 12 months

FDA records hold no clearances under product code MEA in the trailing twelve months.

FDA records show no clearances under product code MEA in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MEA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260