Cleared Traditional

K873421 - KAWASUMI A.V. FISTULA SET

K873421 is an FDA 510(k) clearance for KAWASUMI A.V. FISTULA SET, manufactured by Kawasumi Laboratories Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FKQ cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K873421 · Kawasumi Laboratories Co., Ltd. · Gastroenterology & Urology device
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Oct 1987
Decision
45d
Days
Class 2
Risk

K873421 is an FDA 510(k) clearance for the KAWASUMI A.V. FISTULA SET. Classified as System, Dialysate Delivery, Central Multiple Patient (product code FKQ), Class II - Special Controls.

Submitted by Kawasumi Laboratories Co., Ltd. (Canoga Park, US). The FDA issued a Cleared decision on October 9, 1987 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology 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

FDA 510(k) Submission Details - K873421

510(k) Number K873421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1987
Decision Date October 09, 1987
Days to Decision 45 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 131d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKQ Device Classification - Class 2, Special Controls

Product Code FKQ System, Dialysate Delivery, Central Multiple Patient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FKQ System, Dialysate Delivery, Central Multiple Patient

All 35
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K873421.
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