Cleared Traditional

K873516 - KAWASUMI BLOOD TUBING LINE

K873516 is an FDA 510(k) clearance for KAWASUMI BLOOD TUBING LINE, manufactured by Kawasumi Laboratories Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K873516 · Kawasumi Laboratories Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
35d
Days
Class 2
Risk

K873516 is an FDA 510(k) clearance for the KAWASUMI BLOOD TUBING LINE. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Kawasumi Laboratories Co., Ltd. (Canoga Park, US). The FDA issued a Cleared decision on October 5, 1987 after a review of 35 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.

FDA 510(k) Submission Details - K873516

510(k) Number K873516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1987
Decision Date October 05, 1987
Days to Decision 35 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
96d faster than avg
Panel avg: 131d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJK Device Classification - Class 2, Special Controls

Product Code FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve
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 - FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve

All 76
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K873516.
BIOPRIME TM KIT
K892932 · Hospal · Jun 1989
BLOOD TUBING SET
K884243 · Mediflex Intl. · Dec 1988
LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE
K870722 · National Medical Care, Medical Products Div., Inc. · Sep 1988
S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS
K873455 · Dravon Medical, Inc. · Sep 1987
SERAFLO(TM) BLOODLINES FOR HEMODIALYSIS
K864784 · Cd Medical, Inc. · Jan 1987
ERIKA ARTERIAL LINE 03-9625-9
K860740 · National Medical Care, Medical Products Div., Inc. · Mar 1986
K873516 · KAWASUMI BLOOD TUBING LINE
Download PDF Kawasumi Laboratories…