Cleared Traditional

K010410 - JMS APHERESIS NEEDLE WING EATER

K010410 is the FDA 510(k) clearance for JMS APHERESIS NEEDLE WING EATER by Jms Co., Ltd.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K010410 · Jms Co., Ltd. · General Hospital
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Jun 2001
Decision
128d
Days
Class 2
Risk

K010410 is an FDA 510(k) clearance for the JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Jms Co., Ltd. (Hiroshima, JP). The FDA issued a Cleared decision on June 20, 2001 after a review of 128 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 Jms Co., Ltd. devices

Submission Details

510(k) Number K010410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2001
Decision Date June 20, 2001
Days to Decision 128 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
1d faster than avg
Panel avg: 129d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 243
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