Cleared Traditional

K863128 - PERITONEAL DIALYSIS CATHETERS

K863128 is an FDA 510(k) clearance for PERITONEAL DIALYSIS CATHETERS, manufactured by Thermedics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJS cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K863128 · Thermedics, Inc. · Gastroenterology & Urology device
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Sep 1986
Decision
25d
Days
Class 2
Risk

K863128 is an FDA 510(k) clearance for the PERITONEAL DIALYSIS CATHETERS. Classified as Catheter, Peritoneal, Long-term Indwelling (product code FJS), Class II - Special Controls.

Submitted by Thermedics, Inc. (Woburn, US). The FDA issued a Cleared decision on September 9, 1986 after a review of 25 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 Thermedics, Inc. devices

FDA 510(k) Submission Details - K863128

510(k) Number K863128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1986
Decision Date September 09, 1986
Days to Decision 25 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
105d faster than avg
Panel avg: 130d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJS Device Classification - Class 2, Special Controls

Product Code FJS Catheter, Peritoneal, Long-term Indwelling
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 - FJS Catheter, Peritoneal, Long-term Indwelling

All 19
Devices cleared under the same product code (FJS) and FDA review panel - the closest regulatory comparables to K863128.
PERITONEAL CATHETERS WITH AN ADDED FUNCTION
K890288 · Quinton, Inc. · Mar 1989
TRUDELL BENT CATHETER
K885167 · Sil-Med Corp. · Jan 1989
CHEMO-CATH INTRAPERITONEAL CATHETER
K863819 · Hdc Corp. · Feb 1987
GORE-TEX PERITONEAL CATHETERR
K820909 · W.L. Gore & Associates, Inc. · May 1982
CUFF MATERIAL ON PEDIATRIC SIZE CATH.
K812718 · Quinton, Inc. · Oct 1981
TENCKHOFF PERITONEAL CATHETERS
K812607 · Quinton, Inc. · Oct 1981