510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990312Substantially Equivalent

Avia Pain Medication Delivery System

Amtec Medical, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990312 is the FDA 510(k) clearance record for AVIA PAIN MEDICATION DELIVERY SYSTEM, a class II device, cleared for Amtec Medical on under FDA product code MEA (Pump, Infusion, Pca). FDA records list one 510(k) clearance for Amtec Medical. As of , FDA records show no recalls naming K990312.

Clearance record

Decision date
Received
(80 days to decision)
Product code
MEA Pump, Infusion, Pca
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Amtec Medical 9119 Metric Blvd., Austin TX
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