Cleared Traditional

K242901 - ZZIREN™ Orogastric Tube (FDA 510(k) Clearance)

Also includes:
ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32) ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36) ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40) ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32) ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36) ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)

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

K242901 · Tools For Surgery, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
109d
Days
Class 2
Risk

K242901 is an FDA 510(k) clearance for the ZZIREN™ Orogastric Tube. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Tools For Surgery, LLC (East Setauket, US). The FDA issued a Cleared decision on January 10, 2025 after a review of 109 days - within the typical 510(k) review window.

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 Tools For Surgery, LLC devices

Submission Details

510(k) Number K242901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2024
Decision Date January 10, 2025
Days to Decision 109 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
21d faster than avg
Panel avg: 130d · This submission: 109d
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 648
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K242901.
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