510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K020418Substantially Equivalent

Go Medical Patient Controlled Analgesia Devices

P.T. Greenleaf, Perth, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K020418 is the FDA 510(k) clearance record for GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES, a class II device, cleared for P.T. Greenleaf on under FDA product code MEA (Pump, Infusion, Pca). FDA records list 2 510(k) clearances for P.T. Greenleaf, from to . As of , FDA records show no recalls naming K020418.

Clearance record

Decision date
Received
(446 days to decision)
Product code
MEA Pump, Infusion, Pca
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
P.T. Greenleaf 25 Shann St., Floreat, Perth, AU
510(k) summary
Statement
Third party review
No

Clearances, product code MEA

Trailing 12 months

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

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