Cleared Traditional

K173577 - Guarded Luer Connector

K173577 is an FDA 510(k) clearance for Guarded Luer Connector, manufactured by International Medical Industries, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K173577 · International Medical Industries, Inc. · General Hospital
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Jun 2018
Decision
199d
Days
Class 2
Risk

K173577 is an FDA 510(k) clearance for the Guarded Luer Connector. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by International Medical Industries, Inc. (Pompano Beach, US). The FDA issued a Cleared decision on June 7, 2018 after a review of 199 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all International Medical Industries, Inc. devices

FDA 510(k) Submission Details - K173577

510(k) Number K173577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2017
Decision Date June 07, 2018
Days to Decision 199 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 129d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LHI Set, I.v. Fluid Transfer

All 73
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