Cleared Traditional

K241058 - Lyka® PORT Needle Free Access Device (4170Y)

K241058 is an FDA 510(k) clearance for Lyka PORT Needle Free Access Device (4170Y), manufactured by Quest Medical, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K241058 · Quest Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
244d
Days
Class 2
Risk

K241058 is an FDA 510(k) clearance for the Lyka® PORT Needle Free Access Device (4170Y). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Quest Medical, Inc. (Allen, US). The FDA issued a Cleared decision on December 18, 2024 after a review of 244 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 Quest Medical, Inc. devices

FDA 510(k) Submission Details - K241058

510(k) Number K241058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2024
Decision Date December 18, 2024
Days to Decision 244 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
115d slower than avg
Panel avg: 129d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
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 - FPA Set, Administration, Intravascular

All 768
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K241058.
JetCan® Pro Safety Huber Needle
K242763 · Pfm Medical, Inc. · May 2025
Solution Administration Sets
K243529 · Baxter Healthcare Corporation · Mar 2025
Intravascular Extension Sets and Accessories
K242339 · Baxter Healthcare Corporation · Feb 2025
Ecomed Disposable Administration Sets
K234129 · Ecomed Solutions, LLC · Sep 2024
I.V. Administration Set
K242126 · Bq Plus Medical Co., Ltd. · Aug 2024
Disposable infusion set with needle
K232475 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · May 2024