Cleared Traditional

K121571 - TUBECLEAR

K121571 is an FDA 510(k) clearance for TUBECLEAR, manufactured by Actuated Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K121571 · Actuated Medical, Inc. · Gastroenterology & Urology device
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Jun 2012
Decision
15d
Days
Class 2
Risk

K121571 is an FDA 510(k) clearance for the TUBECLEAR. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Actuated Medical, Inc. (Bellefonte, US). The FDA issued a Cleared decision on June 13, 2012 after a review of 15 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 Actuated Medical, Inc. devices

FDA 510(k) Submission Details - K121571

510(k) Number K121571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2012
Decision Date June 13, 2012
Days to Decision 15 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 131d · This submission: 15d
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 Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 513
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K121571.
BOEHRINGER GASTRIC SIZING TUBE
K130483 · Boehringer Laboratories, LLC · Mar 2013
TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)
K123659 · Actuated Medical, Inc. · Dec 2012
LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
K122030 · Degania Silicone , Ltd. · Sep 2012
PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER
K112860 · Coloplast A/S · Jun 2012
DOBBHOFF DUAL PORT FEEDING TUBE
K112511 · Covidien Lp, Formerly Registered AS Kendall · May 2012
FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
K112342 · Convatec, Inc. · Apr 2012