Cleared Traditional

K003382 - SARSTEDT NEEDLE PROTECTOR

K003382 is an FDA 510(k) clearance for SARSTEDT NEEDLE PROTECTOR, manufactured by Sarstedt, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K003382 · Sarstedt, Inc. · General Hospital
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Mar 2001
Decision
150d
Days
Class 2
Risk

K003382 is an FDA 510(k) clearance for the SARSTEDT NEEDLE PROTECTOR. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Sarstedt, Inc. (Newton, US). The FDA issued a Cleared decision on March 30, 2001 after a review of 150 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K003382

510(k) Number K003382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2000
Decision Date March 30, 2001
Days to Decision 150 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 129d · This submission: 150d
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 673
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K003382.
VACUETTE SPEEDY QUICK-RELEASE HOLDER
K003812 · Greiner Vacuette North America, Inc. · Apr 2001
SHIELDING NEEDLE HOLDER
K003381 · U.S. Safety Syringes Co., Inc. · Apr 2001
DISPO-MED 7.6 LITER SHARPS CONTAINER
K003521 · Master Benefits, Inc. · Apr 2001
BD ECLIPSE HYPODERMIC NEEDLE
K010188 · Bd Medical Systems · Mar 2001
EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET
K003627 · Exelint International, Co. · Feb 2001
SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS
K001965 · North American Medical Products, Inc. · Feb 2001
K003382 · SARSTEDT NEEDLE PROTECTOR
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