Cleared Traditional

K994323 - KAWASUMI LABORATORIES PHILEBOTOMY SET

K994323 is the FDA 510(k) clearance for KAWASUMI LABORATORIES PHILEBOTOMY SET by Kawasumi Laboratories Co., Ltd.. It is a Class 2 General Hospital device (product code LHI) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K994323 · Kawasumi Laboratories Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
77d
Days
Class 2
Risk

K994323 is an FDA 510(k) clearance for the KAWASUMI LABORATORIES PHILEBOTOMY SET. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Kawasumi Laboratories Co., Ltd. (Washington, US). The FDA issued a Cleared decision on March 8, 2000 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 K994323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1999
Decision Date March 08, 2000
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - LHI Set, I.v. Fluid Transfer

All 72
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K994323.
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