510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K082126Substantially Equivalent

Rhapsody MRI

Grantadler Corporation, Appollo Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082126 is the FDA 510(k) clearance record for RHAPSODY MRI, a class II device, cleared for Grantadler Corporation on under FDA product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular). FDA records list 2 510(k) clearances for Grantadler Corporation, from to . As of , FDA records show no recalls naming K082126.

Clearance record

Decision date
Received
(107 days to decision)
Product code
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation
21 CFR 880.5965
Device class
Class II
Review panel
General Hospital
Applicant
Grantadler Corporation 962 Allegro Ln., Appollo Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LJT

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