Cleared Traditional

K850406 - AUTOMATIC PERITONEAL DIALYSIS CYCLER SY...

K850406 is the FDA 510(k) clearance for AUTOMATIC PERITONEAL DIALYSIS CYCLER SY... by Travenol Laboratories, S.A.. It is a Class 2 Gastroenterology & Urology device (product code FKX) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K850406 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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Feb 1985
Decision
17d
Days
Class 2
Risk

K850406 is an FDA 510(k) clearance for the AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on February 21, 1985 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K850406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1985
Decision Date February 21, 1985
Days to Decision 17 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 130d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKX System, Peritoneal, Automatic Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 - FKX System, Peritoneal, Automatic Delivery

All 45
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K850406.
UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
K872652 · Travenol Laboratories, S.A. · Sep 1987
ABBOTT INPERSOL CYCLER 1000
K845042 · Abbott Laboratories · Mar 1985
ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM
K844630 · Organon Teknika Corp. · Mar 1985
RENAL SYSTEMS PERITONEAL ACCESS SYSTEM
K844108 · Renal Systems, Inc. · Jan 1985
SCD STERILE CONNECTION DEVICE
K844144 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1984
EXTENDED LIFE CAPD SOLUTION TRANSFER
K842885 · Travenol Laboratories, S.A. · Oct 1984