Cleared Traditional

K833065 - AUTOMATIC PERITONEAL DIALYSIS CYCLER

K833065 is the FDA 510(k) clearance for AUTOMATIC PERITONEAL DIALYSIS CYCLER 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 81-day FDA review.

K833065 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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Nov 1983
Decision
81d
Days
Class 2
Risk

K833065 is an FDA 510(k) clearance for the AUTOMATIC PERITONEAL DIALYSIS CYCLER. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Walker, US). The FDA issued a Cleared decision on November 28, 1983 after a review of 81 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 K833065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1983
Decision Date November 28, 1983
Days to Decision 81 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
49d faster than avg
Panel avg: 130d · This submission: 81d
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 K833065.
EXTENDED LIFE CAPD SOLUTION TRANSFER
K840224 · Travenol Laboratories, S.A. · Feb 1984
PERITONEAL CATHETER-CHANGES-
K833749 · Quinton, Inc. · Dec 1983
CAPD ULTRAVIOLET GERMICIDAL EXCHANGE
K833595 · Travenol Laboratories, S.A. · Nov 1983
ABBOTT PATIENT ASSIST DEVICE
K830766 · Abbott Laboratories · Mar 1983
BETA-CAP D ADAPTER
K830208 · Quinton, Inc. · Mar 1983
STERILE, DISPOS. SPIKE PROTECTOR-5C4138
K823777 · Travenol Laboratories, S.A. · Jan 1983