Cleared Traditional

K853550 - TRAVENOL CAPD Y SET 5C4354

K853550 is the FDA 510(k) clearance for TRAVENOL CAPD Y SET 5C4354 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 39-day FDA review.

K853550 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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Oct 1985
Decision
39d
Days
Class 2
Risk

K853550 is an FDA 510(k) clearance for the TRAVENOL CAPD Y SET 5C4354. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on October 4, 1985 after a review of 39 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 K853550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1985
Decision Date October 04, 1985
Days to Decision 39 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
91d faster than avg
Panel avg: 130d · This submission: 39d
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 K853550.
EXTERNAL Y VALVE 5C4198
K870145 · Travenol Laboratories, S.A. · Mar 1987
CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186
K860700 · Travenol Laboratories, S.A. · Apr 1986
CAPD TRANSFER SET SPIKE 5C4363
K860230 · Travenol Laboratories, S.A. · Feb 1986
CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353
K852678 · Travenol Laboratories, S.A. · Jul 1985
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