510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911324Substantially Equivalent

Irrigation/aspiration Tubing Set

Biomedical Dynamics, Inc., Burnsville MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911324 is the FDA 510(k) clearance record for IRRIGATION/ASPIRATION TUBING SET, a class II device, cleared for Biomedical Dynamics, Inc. on under FDA product code KDH (Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration). FDA records list 10 510(k) clearances for Biomedical Dynamics, Inc., from to . As of , FDA records show no recalls naming K911324.

Clearance record

Decision date
Received
(90 days to decision)
Product code
KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Biomedical Dynamics, Inc. 12250 Nicollet Ave., Burnsville MN
Third party review
No

Clearances, product code KDH

Trailing 12 months

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

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