Cleared Traditional

K854614 - LONG TERM PERITONEAL CATHETER

K854614 is an FDA 510(k) clearance for LONG TERM PERITONEAL CATHETER, manufactured by Thermadics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJS cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K854614 · Thermadics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
31d
Days
Class 2
Risk

K854614 is an FDA 510(k) clearance for the LONG TERM PERITONEAL CATHETER. Classified as Catheter, Peritoneal, Long-term Indwelling (product code FJS), Class II - Special Controls.

Submitted by Thermadics, Inc. (Woburn, US). The FDA issued a Cleared decision on December 19, 1985 after a review of 31 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 Thermadics, Inc. devices

FDA 510(k) Submission Details - K854614

510(k) Number K854614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1985
Decision Date December 19, 1985
Days to Decision 31 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
99d faster than avg
Panel avg: 130d · This submission: 31d
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 K854614.
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