Cleared Traditional

K974829 - NON-PVC FLUID PATH PORT ACCESS INFUSION...

K974829 is the FDA 510(k) clearance for NON-PVC FLUID PATH PORT ACCESS INFUSION... 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 50-day FDA review.

K974829 · Kawasumi Laboratories Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
50d
Days
Class 2
Risk

K974829 is an FDA 510(k) clearance for the NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET). Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Kawasumi Laboratories Co., Ltd. (Washington, US). The FDA issued a Cleared decision on February 12, 1998 after a review of 50 days - a notably fast clearance cycle.

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: 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 Kawasumi Laboratories Co., Ltd. devices

Submission Details

510(k) Number K974829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1997
Decision Date February 12, 1998
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 129d · This submission: 50d
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
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K974829.
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K964538 · Boston Scientific Corp · Mar 1997