510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822158Substantially Equivalent

Open Heart Tray (Custom Designed)

Megaplast, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822158 is the FDA 510(k) clearance record for OPEN HEART TRAY (CUSTOM DESIGNED), a class I device, cleared for Megaplast, Inc. on under FDA product code KDD (Kit, Surgical Instrument, Disposable). FDA records list 7 510(k) clearances for Megaplast, Inc., from to . As of , FDA records show no recalls naming K822158.

Clearance record

Decision date
Received
(82 days to decision)
Product code
KDD Kit, Surgical Instrument, Disposable
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Megaplast, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KDD

Trailing 12 months

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

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