Cleared Traditional

K823375 - NEPHROSS

K823375 is an FDA 510(k) clearance for NEPHROSS, manufactured by Organon Teknika Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K823375 · Organon Teknika Corp. · Gastroenterology & Urology device
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Dec 1982
Decision
25d
Days
Class 2
Risk

K823375 is an FDA 510(k) clearance for the NEPHROSS, ANDANTE H.F.. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Mchenry, US). The FDA issued a Cleared decision on December 7, 1982 after a review of 25 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K823375

510(k) Number K823375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1982
Decision Date December 07, 1982
Days to Decision 25 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
105d faster than avg
Panel avg: 130d · This submission: 25d
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 124
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K823375.
GAMMA STERILIZED CAPILLARY FLOW DIALYZ
K823778 · Travenol Laboratories, S.A. · Jan 1983
HOSPAL BLOOD LINES
K823707 · Hospal Medical Corp. · Jan 1983
RENAFLO II
K823546 · Renal Systems, Inc. · Dec 1982
EXTRACORPOREAL SINGLE NEEDLE MODULE
K822340 · Extracorporeal Medical Specialities, Inc. · Nov 1982
NEGATIVE PRESSURE ARTERIAL BLOOD LINE
K822796 · Erika, Inc. · Oct 1982
TRIEX-IH DIALYZER
K822738 · Extracorporeal Medical Specialities, Inc. · Sep 1982