510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K173783Substantially Equivalent

SCIg60 Infusion System

Emed Technologies Corporation, El Dorado Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173783 is the FDA 510(k) clearance record for SCIg60 Infusion System, a class II device, cleared for Emed Technologies Corporation on under FDA product code PKP (Immunoglobulin G (Igg) Infusion System). FDA's definition for product code PKP reads: "An Immunoglobulin G (IgG) Infusion System is a prescription device intended for subcutaneous delivery of Immunoglobulin G (IgG) in accordance with the FDA approved labeling". FDA records list 11 510(k) clearances for Emed Technologies Corporation, from to . As of , FDA records show no recalls naming K173783.

Clearance record

Decision date
Received
(366 days to decision)
Product code
PKP Immunoglobulin G (Igg) Infusion System
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Emed Technologies Corporation 1264 Hawks Flight Ct., Suite 200, El Dorado Hills CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PKP

Trailing 12 months
1 clearance under product code PKP in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PKP, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260