510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912053Substantially Equivalent

Open Heart Tray

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

K912053 is the FDA 510(k) clearance record for OPEN HEART TRAY, a class I device, cleared for Medical Device Inspection Co., Inc. on under FDA product code FSM (Tray, Surgical, Instrument). FDA records list 30 510(k) clearances for Medical Device Inspection Co., Inc., from to . As of , FDA records show no recalls naming K912053.

Clearance record

Decision date
Received
(109 days to decision)
Product code
FSM Tray, Surgical, Instrument
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
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 FSM

Trailing 12 months

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

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