Cleared Traditional

K800549 - MODEL TRIEX-L HOLLOW FIBER DIALYZER

K800549 is the FDA 510(k) clearance for MODEL TRIEX-L HOLLOW FIBER DIALYZER by Extracorporeal Medical Specialities, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJI) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K800549 · Extracorporeal Medical Specialities, Inc. · Gastroenterology & Urology device
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Apr 1980
Decision
31d
Days
Class 2
Risk

K800549 is an FDA 510(k) clearance for the MODEL TRIEX-L HOLLOW FIBER DIALYZER. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Extracorporeal Medical Specialities, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1980 after a review of 31 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 Extracorporeal Medical Specialities, Inc. devices

Submission Details

510(k) Number K800549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1980
Decision Date April 10, 1980
Days to Decision 31 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
99d faster than avg
Panel avg: 130d · This submission: 31d
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 54
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K800549.
GF120H DIALYZER
K801045 · Gambro, Inc. · Jun 1980
C-DAK TM 2800 ARTIFICIAL KIDNEY
K800704 · Cordis Corp. · May 1980
GAMBRO LUNDIA FIBER
K800336 · Gambro, Inc. · May 1980
CF/211 CAPILLARY FLOW DIALYZER, #5M1784
K800221 · Travenol Laboratories, S.A. · Feb 1980
TRIEX-2 HOLLOW FIBER DIALYZER
K800270 · Extracorporeal Medical Specialities, Inc. · Feb 1980
C-DAK 2100 ARTIFICIAL KIDNEY
K792419 · Cordis Corp. · Jan 1980