Cleared Traditional

K103254 - PERISTEEN ANAL IRRIGATION SYSTEM

K103254 is the FDA 510(k) clearance for PERISTEEN ANAL IRRIGATION SYSTEM by Coloplast A/S. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K103254 · Coloplast A/S · Gastroenterology & Urology device
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Jan 2011
Decision
89d
Days
Class 2
Risk

K103254 is an FDA 510(k) clearance for the PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTA.... Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on January 31, 2011 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 Coloplast A/S devices

Submission Details

510(k) Number K103254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2010
Decision Date January 31, 2011
Days to Decision 89 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
41d faster than avg
Panel avg: 130d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 170
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K103254.
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K123804 · Hollister, Inc. · Apr 2013
PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER
K112860 · Coloplast A/S · Jun 2012
SAFETY SCREW CONNECTOR
K113719 · Abbott Laboratories · Apr 2012
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
K102391 · C.R. Bard, Inc. · Dec 2010
PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE
K103109 · C.R. Bard, Inc. · Dec 2010
INSTAFLO BOWEL CATHETER SYSTEM KIT
K100273 · Hollister, Inc. · Apr 2010