Cleared Traditional

TubeClear System (K172556) - FDA 510(k) Clearance

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

K172556 · Actuated Medical, Inc. · Gastroenterology & Urology device
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Jun 2018
Decision
309d
Days
Class 2
Risk

K172556 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 June 29, 2018 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K172556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2017
Decision Date June 29, 2018
Days to Decision 309 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
179d slower than avg
Panel avg: 130d · This submission: 309d
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 K172556.
GastroFlush
K180605 · Bionix Development Corporation · Oct 2018
Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port
K180622 · Covidien · Oct 2018
Aspire Introducer Needle
K180725 · Aspire Bariatrics, Inc. · Jul 2018
Bowel Management Device, Bowel Management Irrigation Set
K180026 · Applied Medical Technology, Inc. · Jun 2018
Mic-Key* SF Over-the-Wire Stoma Measuring Device
K173955 · Halyard Health, Inc. · Jan 2018
Gastric Sizing Balloon Catheter
K173355 · Cook Incorporated · Nov 2017