Cleared Traditional

K010038 - NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE

K010038 is an FDA 510(k) clearance for NEEDLE BARN STICK STOPPER WITH SAFETY CAP, manufactured by Cambridge Marketing, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K010038 · Cambridge Marketing, Inc. · General Hospital
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Jan 2001
Decision
19d
Days
Class 2
Risk

K010038 is an FDA 510(k) clearance for the NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Cambridge Marketing, Inc. (Waterford, US). The FDA issued a Cleared decision on January 24, 2001 after a review of 19 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K010038

510(k) Number K010038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2001
Decision Date January 24, 2001
Days to Decision 19 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
110d faster than avg
Panel avg: 129d · This submission: 19d
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 693
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K010038.
EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET
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K003406 · International Medical Device Partners, Inc. · Jan 2001
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION
K003827 · Bio-Plexus, Inc. · Jan 2001
VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET
K000714 · Med-Pro Technologies, Inc. · Dec 2000
K010038 · NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE
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