510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K911216Substantially Equivalent

Infusable

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

K911216 is the FDA 510(k) clearance record for INFUSABLE, a class I device, cleared for Biomedical Dynamics, Inc. on under FDA product code KZD (Infusor, Pressure, For I.V. Bags). FDA records list 10 510(k) clearances for Biomedical Dynamics, Inc., from to . As of , FDA records show no recalls naming K911216.

Clearance record

Decision date
Received
(125 days to decision)
Product code
KZD Infusor, Pressure, For I.V. Bags
Regulation
21 CFR 880.5420
Device class
Class I
Review panel
General Hospital
Applicant
Biomedical Dynamics, Inc. 12250 Nicollet Ave., Burnsville MN
Third party review
No

Clearances, product code KZD

Trailing 12 months

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

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