Cleared Traditional

K802441 - CLIRANS TH10 HOLLOW FIBER DIALYZER

K802441 is the FDA 510(k) clearance for CLIRANS TH10 HOLLOW FIBER DIALYZER by Terumo America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJI) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K802441 · Terumo America, Inc. · Gastroenterology & Urology device
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Dec 1980
Decision
72d
Days
Class 2
Risk

K802441 is an FDA 510(k) clearance for the CLIRANS TH10 HOLLOW FIBER DIALYZER. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 18, 1980 after a review of 72 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 America, Inc. devices

Submission Details

510(k) Number K802441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1980
Decision Date December 18, 1980
Days to Decision 72 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
58d faster than avg
Panel avg: 130d · This submission: 72d
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 89
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K802441.
C-PAK MODEL 12 ARTIFICIAL KIDNEY
K802613 · Cordis Corp. · Jan 1981
NEPHROSS DIALYZER
K802114 · Organon Teknika Corp. · Dec 1980
CLIRANS TH13 HOLLOW FIBER DIALYZER
K802122 · Terumo America, Inc. · Dec 1980
DISSCAP HOLLOW FIBER DIALYZER
K802466 · Hospal Medical Corp. · Nov 1980
RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D.
K801825 · Renal Systems, Inc. · Sep 1980
RENAFLO HOLLOW FIBER DIALYZERS #MP 140
K801826 · Renal Systems, Inc. · Sep 1980