Cleared Traditional

K802122 - CLIRANS TH13 HOLLOW FIBER DIALYZER

K802122 is the FDA 510(k) clearance for CLIRANS TH13 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 105-day FDA review.

K802122 · Terumo America, Inc. · Gastroenterology & Urology device
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Dec 1980
Decision
105d
Days
Class 2
Risk

K802122 is an FDA 510(k) clearance for the CLIRANS TH13 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 105 days - within the typical 510(k) review window.

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 Terumo America, Inc. devices

Submission Details

510(k) Number K802122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1980
Decision Date December 18, 1980
Days to Decision 105 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
25d faster than avg
Panel avg: 130d · This submission: 105d
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 K802122.
CORDIS DOW C-DAK 1.3MRC ARTIF. KIDNEY
K802893 · Cordis Corp. · Feb 1981
C-PAK MODEL 12 ARTIFICIAL KIDNEY
K802613 · Cordis Corp. · Jan 1981
NEPHROSS DIALYZER
K802114 · Organon Teknika Corp. · Dec 1980
CLIRANS TH10 HOLLOW FIBER DIALYZER
K802441 · 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