Cleared Traditional

K112268 - CODAN SAFEFEED ENTERAL FEEDING RESERVOIR

K112268 is an FDA 510(k) clearance for CODAN SAFEFEED ENTERAL FEEDING RESERVOIR, manufactured by Codan US Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K112268 · Codan US Corp. · Gastroenterology & Urology device
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Mar 2012
Decision
224d
Days
Class 2
Risk

K112268 is an FDA 510(k) clearance for the CODAN SAFEFEED ENTERAL FEEDING RESERVOIR. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Codan US Corp. (Santa Ana, US). The FDA issued a Cleared decision on March 19, 2012 after a review of 224 days - an extended review 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: 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 Codan US Corp. devices

FDA 510(k) Submission Details - K112268

510(k) Number K112268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2011
Decision Date March 19, 2012
Days to Decision 224 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 131d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 498
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K112268.
SAFETY SCREW CONNECTOR
K113719 · Abbott Laboratories · Apr 2012
NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES
K120182 · Neomed, Inc. · Apr 2012
ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN
K112863 · Acta Medical, LLC · Mar 2012
AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET
K120272 · Kentec Medical, Inc. · Feb 2012
CORTRAK ENTERAL ACCESS DEVICE
K113351 · Corpak Medsystems · Jan 2012
MED GRAVITY SET, IMED PUMP SET
K102712 · Imed Technology, Inc. · Dec 2011

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.