Cleared Traditional

K883748 - RENAK-E & RENEK-A SERIES HOLLOW FIBER D...

K883748 is the FDA 510(k) clearance for RENAK-E & RENEK-A SERIES HOLLOW FIBER D... by Kawasumi Laboratories Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FJI) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K883748 · Kawasumi Laboratories Co., Ltd. · Gastroenterology & Urology device
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Jan 1989
Decision
152d
Days
Class 2
Risk

K883748 is an FDA 510(k) clearance for the RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Kawasumi Laboratories Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on January 31, 1989 after a review of 152 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kawasumi Laboratories Co., Ltd. devices

Submission Details

510(k) Number K883748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1988
Decision Date January 31, 1989
Days to Decision 152 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 130d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJI Dialyzer, Capillary, Hollow Fiber
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 - FJI Dialyzer, Capillary, Hollow Fiber

All 85
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K883748.
CLIRANS HOLLOW FIBER HEMODIALYZER (WET)
K891477 · Terumo Medical Corp. · Jun 1989
GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY
K892523 · Gambro, Inc. · May 1989
GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER
K890111 · Gambro, Inc. · Feb 1989
CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.100
K883534 · Baxter Healthcare Corp · Oct 1988
CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170
K883644 · Baxter Healthcare Corp · Oct 1988
GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER
K883589 · Gambro, Inc. · Sep 1988