Cleared Traditional

K840845 - HOLLOW FIBER DIALYZERS

K840845 is the FDA 510(k) clearance for HOLLOW FIBER DIALYZERS by Travenol Laboratories, S.A.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K840845 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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Aug 1984
Decision
174d
Days
Class 2
Risk

K840845 is an FDA 510(k) clearance for the HOLLOW FIBER DIALYZERS. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on August 16, 1984 after a review of 174 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K840845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date August 16, 1984
Days to Decision 174 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
44d slower than avg
Panel avg: 130d · This submission: 174d
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 114
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K840845.
ASN MONITOR SINGLE NEEDLE MONITOR
K843531 · Organon Teknika Corp. · Nov 1984
HOLLOW FIBER DIALYZER
K843632 · Travenol Laboratories, S.A. · Oct 1984
CAPILLARY FLOW DIALYZERS
K840937 · Travenol Laboratories, S.A. · Sep 1984
ERIKA NEGATIVE PRESS. ARTERIAL BLOOD
K842436 · Erika, Inc. · Jul 1984
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER
K831173 · Erika, Inc. · Jun 1984
FILTRYZER HOLLOW FIBER ARTIFICIAL KID-
K831174 · Erika, Inc. · Jun 1984