510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K911369Substantially Equivalent

Qualtex Light Handle and Light Handle Cover

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

K911369 is the FDA 510(k) clearance record for QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER, a class I device, cleared for Deroyal Industries, Inc. on under FDA product code MDM (Instrument, Manual, Surgical, General Use). FDA records list 92 510(k) clearances for Deroyal Industries, Inc., from to . As of , FDA records show no recalls naming K911369.

Clearance record

Decision date
Received
(46 days to decision)
Product code
MDM Instrument, Manual, Surgical, General Use
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Deroyal Industries, Inc. 200 Debusk Ln., Powell TN
Third party review
No

Clearances, product code MDM

Trailing 12 months

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

FDA records show no clearances under product code MDM in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MDM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260