Cleared Traditional

K991042 - ASH ADVANTAGE PERITONEAL CATHETER

K991042 is an FDA 510(k) clearance for ASH ADVANTAGE PERITONEAL CATHETER, manufactured by Janin Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJS cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K991042 · Janin Group, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
88d
Days
Class 2
Risk

K991042 is an FDA 510(k) clearance for the ASH ADVANTAGE PERITONEAL CATHETER. Classified as Catheter, Peritoneal, Long-term Indwelling (product code FJS), Class II - Special Controls.

Submitted by Janin Group, Inc. (Aurora, US). The FDA issued a Cleared decision on June 25, 1999 after a review of 88 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 Janin Group, Inc. devices

FDA 510(k) Submission Details - K991042

510(k) Number K991042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1999
Decision Date June 25, 1999
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 131d · This submission: 88d
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 29
Devices cleared under the same product code (FJS) and FDA review panel - the closest regulatory comparables to K991042.
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