510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031566Substantially Equivalent

Syndeo Pca Syringe Pump, Model 2L3113

Baxter Healthcare Corporation, Deerfield Lake IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031566 is the FDA 510(k) clearance record for SYNDEO PCA SYRINGE PUMP, MODEL 2L3113, 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 one recall naming K031566.

Clearance record

Decision date
Received
(92 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 One Baxter Pkwy., Deerfield Lake IL
510(k) summary
Summary PDF
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MEA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260