Cleared Traditional

K822338 - KF-101-10 DIALYZER

K822338 is an FDA 510(k) clearance for KF-101-10 DIALYZER, manufactured by Extracorporeal Medical Specialities, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K822338 · Extracorporeal Medical Specialities, Inc. · Gastroenterology & Urology device
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Feb 1983
Decision
196d
Days
Class 2
Risk

K822338 is an FDA 510(k) clearance for the KF-101-10 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 February 16, 1983 after a review of 196 days - an extended review 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: 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 Extracorporeal Medical Specialities, Inc. devices

FDA 510(k) Submission Details - K822338

510(k) Number K822338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1982
Decision Date February 16, 1983
Days to Decision 196 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
65d slower than avg
Panel avg: 131d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOC Device Classification - Class 2, Special Controls

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 134
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K822338.
AMPCO KIDNEY DIALYSIS TRAY
K823839 · Associated Medical Products Co. · Mar 1983
C-DAK ARTIFICIAL KIDNEY
K830729 · Cordis Corp. · Mar 1983
KF-101-07 DIALYZER
K822337 · Extracorporeal Medical Specialities, Inc. · Feb 1983
KF-101-13 DIALYZER
K822339 · Extracorporeal Medical Specialities, Inc. · Feb 1983
MEDISYSTEMS FISTULA NEEDLES
K823068 · Medisystems Corp. · Jan 1983
KF-E SERIES HOLLOW FIBER DIALYZER
K823069 · Medisystems Corp. · Jan 1983