510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912116Substantially Equivalent

Pressure Sore Management Kit

Medical Device Inspection Company, Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912116 is the FDA 510(k) clearance record for PRESSURE SORE MANAGEMENT KIT, a class II device, cleared for Medical Device Inspection Co., Inc. on under FDA product code MCY (Wound Dressing Kit). FDA's definition for product code MCY reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the...". FDA records list 30 510(k) clearances for Medical Device Inspection Co., Inc., from to . As of , FDA records show no recalls naming K912116.

Clearance record

Decision date
Received
(157 days to decision)
Product code
MCY Wound Dressing Kit
Regulation
21 CFR 880.5075
Device class
Class II
Review panel
General Hospital
Applicant
Medical Device Inspection Co., Inc. 55 Northern Blvd., Suite 301, Great Neck NY
510(k) summary
Statement
Third party review
No

Clearances, product code MCY

Trailing 12 months

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

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