Cleared Traditional

K833595 - CAPD ULTRAVIOLET GERMICIDAL EXCHANGE

K833595 is an FDA 510(k) clearance for CAPD ULTRAVIOLET GERMICIDAL EXCHANGE, manufactured by Travenol Laboratories, S.A.. The device is a Class 2 Gastroenterology & Urology device with product code FKX cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K833595 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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Nov 1983
Decision
48d
Days
Class 2
Risk

K833595 is an FDA 510(k) clearance for the CAPD ULTRAVIOLET GERMICIDAL EXCHANGE. 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 29, 1983 after a review of 48 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

FDA 510(k) Submission Details - K833595

510(k) Number K833595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date November 29, 1983
Days to Decision 48 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
83d faster than avg
Panel avg: 131d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKX Device Classification - Class 2, Special Controls

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 64
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K833595.
EXTENDED LIFE CAPD SOLUTION TRANSFER
K842885 · Travenol Laboratories, S.A. · Oct 1984
EXTENDED LIFE CAPD SOLUTION TRANSFER
K840224 · Travenol Laboratories, S.A. · Feb 1984
PERITONEAL CATHETER-CHANGES-
K833749 · Quinton, Inc. · Dec 1983
AUTOMATIC PERITONEAL DIALYSIS CYCLER
K833065 · Travenol Laboratories, S.A. · Nov 1983
AMPERCIDE DISINFECTANT ACCESSORY TO -
K830881 · American Medical Products, Inc. · Jun 1983
EMPTY DIALYSATE CONTAINER BB-69
K830689 · Delmed, Inc. · Mar 1983