Cleared Traditional

K870145 - EXTERNAL Y VALVE 5C4198

K870145 is the FDA 510(k) clearance for EXTERNAL Y VALVE 5C4198 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 56-day FDA review.

K870145 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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Mar 1987
Decision
56d
Days
Class 2
Risk

K870145 is an FDA 510(k) clearance for the EXTERNAL Y VALVE 5C4198. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Round Lake, US). The FDA issued a Cleared decision on March 10, 1987 after a review of 56 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 K870145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1987
Decision Date March 10, 1987
Days to Decision 56 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
74d faster than avg
Panel avg: 130d · This submission: 56d
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 K870145.
AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)
K873984 · Travenol Laboratories, S.A. · Oct 1987
CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN.
K871049 · Abbott Laboratories · Apr 1987
CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM.
K871050 · Abbott Laboratories · Apr 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
TRAVENOL CAPD Y SET 5C4354
K853550 · Travenol Laboratories, S.A. · Oct 1985