Cleared Special

K102994 - K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR

K102994 is an FDA 510(k) clearance for K-SHIELD ARTERIAL VENOUS FISTULA SET WI..., manufactured by Kawasumi Laboratories, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 26-day FDA review.

K102994 · Kawasumi Laboratories, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
26d
Days
Class 2
Risk

K102994 is an FDA 510(k) clearance for the K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Kawasumi Laboratories, Inc. (Tampa, US). The FDA issued a Cleared decision on November 3, 2010 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K102994

510(k) Number K102994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2010
Decision Date November 03, 2010
Days to Decision 26 days
Submission Type Special
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
103d faster than avg
Panel avg: 129d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 695
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K102994.
IMC HYPODERMIC NEEDLE
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K102774 · Greiner Bio-One North America, Inc. · Oct 2010
FASTX STERNAL INTRAOSSEOUS DEVICE
K100124 · Pyng Medical Corp. · Aug 2010
ZIRCONIA SYRINGE NEEDLE
K093043 · Kuo Tai Hospital Managements & Consultant Co., Ltd. · Aug 2010
K102994 · K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR
Download PDF FDA Summary Kawasumi Laboratories…