510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K935985Substantially Equivalent

Deroyal Critical Care Disposable Waste Station

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

K935985 is the FDA 510(k) clearance record for DEROYAL CRITICAL CARE DISPOSABLE WASTE STATION, a class II device, cleared for Deroyal Industries, Inc. on under FDA product code DQO (Catheter, Intravascular, Diagnostic). FDA records list 92 510(k) clearances for Deroyal Industries, Inc., from to . As of , FDA records show no recalls naming K935985.

Clearance record

Decision date
Received
(372 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Deroyal Industries, Inc. 200 Debusk Ln., Powell TN
510(k) summary
Statement
Third party review
No

Clearances, product code DQO

Trailing 12 months
3 clearances under product code DQO in the twelve months to November 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DQO, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260
November 20260