Cleared Traditional

K103254 - PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE

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

K103254 · Coloplast A/S · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K103254

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
42d faster than avg
Panel avg: 131d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

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 532
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K103254.
BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION
K112434 · Bd Medical Surgical · Sep 2011
SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE
K110005 · Syncro Medical Innovations, Inc. · Aug 2011
ENDOFLIP GASTRIC TUBE
K110529 · Crospon, Ltd. · Jul 2011
IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT
K102572 · Sainath Intellectual Properties, LLC · Dec 2010
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
K103254 · PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
Download PDF FDA Summary Coloplast A/S