Cleared Traditional

K812802 - CAPD U.V. GERMICIDAL CONNECTION SYSTEM

K812802 is the FDA 510(k) clearance for CAPD U.V. GERMICIDAL CONNECTION SYSTEM by Travenol Laboratories, S.A.. It is a Class 2 Gastroenterology & Urology device (product code KDJ) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K812802 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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Mar 1982
Decision
147d
Days
Class 2
Risk

K812802 is an FDA 510(k) clearance for the CAPD U.V. GERMICIDAL CONNECTION SYSTEM. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Walker, US). The FDA issued a Cleared decision on March 2, 1982 after a review of 147 days - within the typical 510(k) review window.

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: 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 K812802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1981
Decision Date March 02, 1982
Days to Decision 147 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
17d slower than avg
Panel avg: 130d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDJ Set, Administration, For Peritoneal Dialysis, Disposable
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 - KDJ Set, Administration, For Peritoneal Dialysis, Disposable

All 78
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K812802.
EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153
K851207 · Travenol Laboratories, S.A. · Apr 1985
COMPACT EXCHANGE DEVICE 5C4197
K851208 · Travenol Laboratories, S.A. · Apr 1985
CARD U.V. GERMICIDAL CHAMBER II
K820546 · Travenol Laboratories, S.A. · Jun 1982
GAMBRO PERITONEAL DIALYSIS FLUID LINES
K811294 · Gambro, Inc. · Jun 1981
INPERSOL CAPD BAG PORT CLAMP
K803300 · Abbott Laboratories · Jan 1981
INPERSOL-CAPD ADMINISTRATION SET
K801881 · Abbott Laboratories · Oct 1980