Cleared Traditional

K801194 - CLIRANS TE07 HOLLOW FIBER DIALYZER

K801194 is the FDA 510(k) clearance for CLIRANS TE07 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 85-day FDA review.

K801194 · Terumo America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1980
Decision
85d
Days
Class 2
Risk

K801194 is an FDA 510(k) clearance for the CLIRANS TE07 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 August 12, 1980 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 America, Inc. devices

Submission Details

510(k) Number K801194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1980
Decision Date August 12, 1980
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.

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 K801194.
RENAFLO HOLLOW FIBER DIALYZERS #MP 140
K801826 · Renal Systems, Inc. · Sep 1980
RENAFLO HOLLOW FIBER DIALYZER #100.1
K801827 · Renal Systems, Inc. · Sep 1980
CLIRANS TE10 HOLLOW FIBER DIALYZER
K801192 · Terumo America, Inc. · Aug 1980
COBE HF80, CAT. #18-580
K801178 · Cobe Laboratories, Inc. · Jul 1980
EXTRACORPOREALS' ALTERNATE MEMBRANE
K801344 · Extracorporeal Medical Specialities, Inc. · Jul 1980
GF-120-L DIALYZER
K801370 · Gambro, Inc. · Jul 1980