Cleared Traditional

K151341 - Turbo High-Flow Non-coring Needle

K151341 is an FDA 510(k) clearance for Turbo High-Flow Non-coring Needle, manufactured by Norfolk Medical. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K151341 · Norfolk Medical · General Hospital
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Aug 2015
Decision
93d
Days
Class 2
Risk

K151341 is an FDA 510(k) clearance for the Turbo High-Flow Non-coring Needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Norfolk Medical (Skokie, US). The FDA issued a Cleared decision on August 20, 2015 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 880.5570 - 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 Norfolk Medical devices

FDA 510(k) Submission Details - K151341

510(k) Number K151341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2015
Decision Date August 20, 2015
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.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 445
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K151341.
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K143437 · Htl-Strefa S.A · Jun 2015
K-Pack II Needle - 29G x 5/16 Thin Wall
K151398 · Terumo Europe N.V. · Jun 2015