Cleared Traditional

K921902 - PORT ACCESS NEEDLE

K921902 is the FDA 510(k) clearance for PORT ACCESS NEEDLE by Kawasumi Laboratories Co., Ltd.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 462-day FDA review.

K921902 · Kawasumi Laboratories Co., Ltd. · General Hospital
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Jul 1993
Decision
462d
Days
Class 2
Risk

K921902 is an FDA 510(k) clearance for the PORT ACCESS NEEDLE. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Kawasumi Laboratories Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on July 28, 1993 after a review of 462 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Kawasumi Laboratories Co., Ltd. devices

Submission Details

510(k) Number K921902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1992
Decision Date July 28, 1993
Days to Decision 462 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
333d slower than avg
Panel avg: 129d · This submission: 462d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
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 - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 122
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