510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910257Substantially Equivalent

Baxa Pca Infusor

Baxa Corp., Sub. of Cook Group, Inc., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910257 is the FDA 510(k) clearance record for BAXA PCA INFUSOR, a class II device, cleared for Baxa Corp., Sub. of Cook Group, Inc. on under FDA product code MEA (Pump, Infusion, Pca). FDA records list 16 510(k) clearances for Baxa Corp., Sub. of Cook Group, Inc., from to . As of , FDA records show no recalls naming K910257.

Clearance record

Decision date
Received
(289 days to decision)
Product code
MEA Pump, Infusion, Pca
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Baxa Corp., Sub. of Cook Group, Inc. 13760 E. Arapahoe Rd., Englewood CO
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