Cleared Traditional

TubeClear System (K200646) - FDA 510(k) Clearance

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

K200646 · Actuated Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2020
Decision
267d
Days
Class 2
Risk

K200646 is an FDA 510(k) clearance for the TubeClear System. 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 December 4, 2020 after a review of 267 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 Actuated Medical, Inc. devices

Submission Details

510(k) Number K200646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2020
Decision Date December 04, 2020
Days to Decision 267 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
137d slower than avg
Panel avg: 130d · This submission: 267d
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 141
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K200646.
Safety Trocar Cannula
K211072 · Boston Scientific Corporation · Apr 2021
Enteral Feeding Catheter
K202748 · Medcaptain Life Science Co., Ltd. · Apr 2021
ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube
K203133 · Envizion Medical , Ltd. · Mar 2021
Nutriglide(TM) Nasal Feeding Tube
K202539 · Applied Medical Technology, Inc. · Oct 2020
Entuit Nasal Jejunal Feeding Tube
K201322 · Wilson-Cook Medical, Inc. · Jun 2020
Standard Bougie
K191885 · Standard Bariatrics · Apr 2020