510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K173577Substantially Equivalent

Guarded Luer Connector

Intl. Medical Industries, Pompano Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173577 is the FDA 510(k) clearance record for Guarded Luer Connector, a class II device, cleared for International Medical Industries, Inc. on under FDA product code LHI (Set, I.V. Fluid Transfer). FDA records list 10 510(k) clearances for INTL. MEDICAL INDUSTRIES, from to . As of , FDA records show one recall naming K173577.

Clearance record

Decision date
Received
(199 days to decision)
Product code
LHI Set, I.V. Fluid Transfer
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
International Medical Industries, Inc. 2981 Gateway Dr., Pompano Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LHI

Trailing 12 months
2 clearances under product code LHI in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LHI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260