Cleared Traditional

SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP DEVICE (K944680) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 181
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K944680.
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MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT)
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PISTON SYRINGES
K944757 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1995
CHEMOTHERAPY SHARPS DISPOSAL CONTAINERS
K943722 · Baxter Healthcare Corp · Nov 1994
B-D GUARDIAN NESTABLE SHARPS COLLECTORS
K943575 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1994