510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895427Substantially Equivalent

Mediseal Suction Canister

DeRoyal Industries, Inc., Powell TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895427 is the FDA 510(k) clearance record for MEDISEAL SUCTION CANISTER, a class II device, cleared for Deroyal Industries, Inc. on under FDA product code DWD (Suction Control, Intracardiac, Cardiopulmonary Bypass). FDA records list 92 510(k) clearances for Deroyal Industries, Inc., from to . As of , FDA records show no recalls naming K895427.

Clearance record

Decision date
Received
(136 days to decision)
Product code
DWD Suction Control, Intracardiac, Cardiopulmonary Bypass
Regulation
21 CFR 870.4430
Device class
Class II
Review panel
Cardiovascular
Applicant
Deroyal Industries, Inc. 200 Debusk Ln., Powell TN
Third party review
No

Clearances, product code DWD

Trailing 12 months

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

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