510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960616Substantially Equivalent

Vitaflow Suction/aspiration Tubing Set

Vital Concepts, Inc., Grand Rapids MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960616 is the FDA 510(k) clearance record for VITAFLOW SUCTION/ASPIRATION TUBING SET, a class II device, cleared for Vital Concepts, Inc. on under FDA product code BYY (Tube, Aspirating, Flexible, Connecting). FDA records list 4 510(k) clearances for Vital Concepts, Inc., from to . As of , FDA records show 6 recalls naming K960616.

Clearance record

Decision date
Received
(83 days to decision)
Product code
BYY Tube, Aspirating, Flexible, Connecting
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Vital Concepts, Inc. 5090 Kendrick Ct. SE, Grand Rapids MI
510(k) summary
Statement
Third party review
No

Clearances, product code BYY

Trailing 12 months

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

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