Cleared Traditional

K860700 - CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186 (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K860700 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
41d
Days
Class 2
Risk

K860700 is an FDA 510(k) clearance for the CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186. 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 April 7, 1986 after a review of 41 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 K860700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1986
Decision Date April 07, 1986
Days to Decision 41 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 130d · This submission: 41d
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 112
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K860700.
stay•safe® catheter extension set with Safe- Lock, 12 inch
K250404 · Fresenius Medical Care Renal Therapies Group, LLC · Apr 2025
MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A
K231849 · Baxter Healthcare · Mar 2024
15L Cycler Drainage Bag
K214016 · Baxter Healthcare Corporation · Mar 2022