510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781364Substantially Equivalent

Pint Bottle Well

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

K781364 is the FDA 510(k) clearance record for PINT BOTTLE WELL, a class I device, cleared for Baxa Corp., Sub. of Cook Group, Inc. on under FDA product code KYX (Dispenser, Liquid Medication). 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 K781364.

Clearance record

Decision date
Received
(71 days to decision)
Product code
KYX Dispenser, Liquid Medication
Regulation
21 CFR 880.6430
Device class
Class I
Review panel
General Hospital
Applicant
Baxa Corp., Sub. of Cook Group, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KYX

Trailing 12 months

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

FDA records show no clearances under product code KYX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KYX, 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