Cleared Traditional

K031058 - CORD STICK MULTIPLE DRAW SYSTEM

K031058 is an FDA 510(k) clearance for CORD STICK MULTIPLE DRAW SYSTEM, manufactured by Cord Stick Corp.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K031058 · Cord Stick Corp. · General Hospital
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Jun 2003
Decision
71d
Days
Class 2
Risk

K031058 is an FDA 510(k) clearance for the CORD STICK MULTIPLE DRAW SYSTEM. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Cord Stick Corp. (Modesto, US). The FDA issued a Cleared decision on June 13, 2003 after a review of 71 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.

View all Cord Stick Corp. devices

FDA 510(k) Submission Details - K031058

510(k) Number K031058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2003
Decision Date June 13, 2003
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
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 424
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K031058.
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SURE-LOK
K021315 · Vital Signs, Inc. · Aug 2002
NIPRO HYPODERMIC NEEDLE
K013293 · Nipro Medical Corp. · Dec 2001