Cleared Traditional

ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 (K083153) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K083153 · Hollister, Inc. · Gastroenterology & Urology device
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Feb 2009
Decision
103d
Days
Class 2
Risk

K083153 is an FDA 510(k) clearance for the ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on February 4, 2009 after a review of 103 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hollister, Inc. devices

Submission Details

510(k) Number K083153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received October 24, 2008
Decision Date February 04, 2009
Days to Decision 103 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 130d · This submission: 103d
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 125
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K083153.
SAFETY SCREW CONNECTOR
K113719 · Abbott Laboratories · Apr 2012
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K102391 · C.R. Bard, Inc. · Dec 2010
PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE
K103109 · C.R. Bard, Inc. · Dec 2010
2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K081739 · Boston Scientific Corp · Dec 2008
ENTERAL ONLY EXTENSION SET
K082654 · Respironics, Inc. · Nov 2008
BARD DIGNICARE STOOL MANAGEMENT SYSTEM
K073598 · C.R. Bard, Inc. · Jun 2008