Cleared Traditional

PEF TUBE (K071579) - FDA 510(k) Clearance

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

K071579 · N.M. Beale Co., Inc. · Gastroenterology & Urology device
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Nov 2007
Decision
165d
Days
Class 2
Risk

K071579 is an FDA 510(k) clearance for the PEF TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by N.M. Beale Co., Inc. (Ayer, US). The FDA issued a Cleared decision on November 20, 2007 after a review of 165 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 N.M. Beale Co., Inc. devices

Submission Details

510(k) Number K071579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2007
Decision Date November 20, 2007
Days to Decision 165 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
35d slower than avg
Panel avg: 130d · This submission: 165d
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 K071579.
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K072476 · Boston Scientific Corporation · Dec 2007
BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE
K063118 · C.R. Bard, Inc. · Feb 2007
FASTRAC GASTRIC ACCESS PORT KIT
K033562 · C.R. Bard, Inc. · Dec 2003
COOK GASTRIC SIZING BALLOON CATHETER
K030841 · Cook, Inc. · Jul 2003