Cleared Traditional

K822738 - TRIEX-IH DIALYZER

K822738 is the FDA 510(k) clearance for TRIEX-IH DIALYZER by Extracorporeal Medical Specialities, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K822738 · Extracorporeal Medical Specialities, Inc. · Gastroenterology & Urology device
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Sep 1982
Decision
15d
Days
Class 2
Risk

K822738 is an FDA 510(k) clearance for the TRIEX-IH DIALYZER. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Extracorporeal Medical Specialities, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 24, 1982 after a review of 15 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 K822738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1982
Decision Date September 24, 1982
Days to Decision 15 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
115d faster than avg
Panel avg: 130d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOC Accessories, Blood Circuit, Hemodialysis
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 80
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K822738.
GAMMA STERILIZED CAPILLARY FLOW DIALYZ
K823778 · Travenol Laboratories, S.A. · Jan 1983
NEPHROSS, ANDANTE H.F.
K823375 · Organon Teknika Corp. · Dec 1982
EXTRACORPOREAL SINGLE NEEDLE MODULE
K822340 · Extracorporeal Medical Specialities, Inc. · Nov 1982
TS-000 ARTERIOVENOUS BLOOD TUBING SET
K822283 · Extracorporeal Medical Specialities, Inc. · Aug 1982
LUNDIA 10-5 N PARALLEL FLOW DIALYZER
K822049 · Gambro, Inc. · Aug 1982
GF-180-M & GF-180-H HEMODIALYZERS
K821367 · Gambro, Inc. · May 1982