Cleared Traditional

K812648 - EHTOX GASTRIC LAVAGE KIT #2050 & #2070

K812648 is an FDA 510(k) clearance for EHTOX GASTRIC LAVAGE KIT #2050 & #2070, manufactured by Ethox Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K812648 · Ethox Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1981
Decision
12d
Days
Class 2
Risk

K812648 is an FDA 510(k) clearance for the EHTOX GASTRIC LAVAGE KIT #2050 & #2070. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Ethox Corp. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1981 after a review of 12 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 Ethox Corp. devices

FDA 510(k) Submission Details - K812648

510(k) Number K812648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1981
Decision Date September 29, 1981
Days to Decision 12 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 131d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 468
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K812648.
ARGYLE INDWELL FEEDING TUBE
K820442 · Sherwood Medical Co. · Mar 1982
VYGON ENTERNAL NUTRITION TUBES
K820176 · Exco, Inc. · Feb 1982
CELESTIN PULSION ESOPHOGEAL PROSTHESIS
K813169 · Inmed Corp. · Dec 1981
CARTMILL/BARRY FEEDING TUBE
K812427 · Impra, Inc. · Sep 1981
ENTER-A1 ENTERIC FEEDING TUBE
K812279 · Medi-Tech, Inc. · Aug 1981
ENTRI ENTERNAL FEEDING SET
K811683 · Biosearch Medical Products, Inc. · Jul 1981