510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K821185Substantially Equivalent

New Support Sys. for Bedridden Patients

Dase Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821185 is the FDA 510(k) clearance record for NEW SUPPORT SYS. FOR BEDRIDDEN PATIENTS, a class II device, cleared for Dase Co. on under FDA product code FNL (Bed, Ac-Powered Adjustable Hospital). FDA records list one 510(k) clearance for Dase Co. As of , FDA records show no recalls naming K821185.

Clearance record

Decision date
Received
(140 days to decision)
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Regulation
21 CFR 880.5100
Device class
Class II
Review panel
General Hospital
Applicant
Dase Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FNL

Trailing 12 months

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

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