Cleared Special

K012646 - TERUMO 30 GAUGE HYPODERMIC NEEDLE

K012646 is an FDA 510(k) clearance for TERUMO 30 GAUGE HYPODERMIC NEEDLE, manufactured by Terumo Medical Corp.. The device is a Class 2 General Hospital device with product code FMI cleared through the Special 510(k) pathway after a 14-day FDA review.

K012646 · Terumo Medical Corp. · General Hospital
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Aug 2001
Decision
14d
Days
Class 2
Risk

K012646 is an FDA 510(k) clearance for the TERUMO 30 GAUGE HYPODERMIC NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on August 27, 2001 after a review of 14 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.

View all Terumo Medical Corp. devices

FDA 510(k) Submission Details - K012646

510(k) Number K012646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date August 27, 2001
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
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 274
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K012646.
NIPRO HYPODERMIC NEEDLE
K013293 · Nipro Medical Corp. · Dec 2001
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K011984 · Becton, Dickinson & CO · Aug 2001
BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
K003461 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 2001
B-D ULTRA-FINE III PEN NEEDLE
K002938 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 2000
SIMPLICITY DISPOSABLE PEN NEEDLE
K002180 · Sterling Medivations, Inc. · Oct 2000