Cleared Traditional

K891477 - CLIRANS HOLLOW FIBER HEMODIALYZER (WET)

K891477 is an FDA 510(k) clearance for CLIRANS HOLLOW FIBER HEMODIALYZER (WET), manufactured by Terumo Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K891477 · Terumo Medical Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jun 1989
Decision
85d
Days
Class 2
Risk

K891477 is an FDA 510(k) clearance for the CLIRANS HOLLOW FIBER HEMODIALYZER (WET). Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on June 9, 1989 after a review of 85 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K891477

510(k) Number K891477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1989
Decision Date June 09, 1989
Days to Decision 85 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
45d faster than avg
Panel avg: 130d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJI Device Classification - Class 2, Special Controls

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 97
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K891477.
BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.
K903567 · Organon Teknika Corp. · Sep 1990
GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER
K902481 · Gambro, Inc. · Jul 1990
HOLLOW FIBER DIALYZER FOCUS 70H
K893677 · National Medical Care, Medical Products Div., Inc. · Jul 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