Cleared Traditional

K023917 - WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR

K023917 is an FDA 510(k) clearance for WINGED NEEDLE SETS WITH AN ANTINEEDLE S..., manufactured by Kawasumi Laboratories, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K023917 · Kawasumi Laboratories, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
93d
Days
Class 2
Risk

K023917 is an FDA 510(k) clearance for the WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Kawasumi Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on February 26, 2003 after a review of 93 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K023917

510(k) Number K023917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2002
Decision Date February 26, 2003
Days to Decision 93 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
36d faster than avg
Panel avg: 129d · This submission: 93d
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 1172
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K023917.
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K030137 · Avail Medical Products, Inc. · Feb 2003
K023917 · WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR
Download PDF FDA Summary Kawasumi Laboratories…