Cleared Traditional

K944680 - SPLIT TOP WING NEEDLE CAP WITH OPTIONAL...

K944680 is an FDA 510(k) clearance for SPLIT TOP WING NEEDLE CAP WITH OPTIONAL..., manufactured by Researched, Novel Medical Devices (Rn/Md). The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K944680 · Researched, Novel Medical Devices (Rn/Md) · General Hospital
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Jan 1995
Decision
131d
Days
Class 2
Risk

K944680 is an FDA 510(k) clearance for the SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP.... Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Researched, Novel Medical Devices (Rn/Md) (Sherman Oaks, US). The FDA issued a Cleared decision on January 31, 1995 after a review of 131 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 Researched, Novel Medical Devices (Rn/Md) devices

FDA 510(k) Submission Details - K944680

510(k) Number K944680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1994
Decision Date January 31, 1995
Days to Decision 131 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 129d · This submission: 131d
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 264
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K944680.
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