Cleared Traditional

K813169 - CELESTIN PULSION ESOPHOGEAL PROSTHESIS

K813169 is an FDA 510(k) clearance for CELESTIN PULSION ESOPHOGEAL PROSTHESIS, manufactured by Inmed Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K813169 · Inmed Corp. · Gastroenterology & Urology device
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Dec 1981
Decision
21d
Days
Class 2
Risk

K813169 is an FDA 510(k) clearance for the CELESTIN PULSION ESOPHOGEAL PROSTHESIS. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Inmed Corp. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1981 after a review of 21 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.

FDA 510(k) Submission Details - K813169

510(k) Number K813169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1981
Decision Date December 03, 1981
Days to Decision 21 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
110d faster than avg
Panel avg: 131d · This submission: 21d
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 651
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K813169.
VYGON ENTERNAL NUTRITION TUBES
K820176 · Exco, Inc. · Feb 1982
FECAL SANITARY TUBE
K813526 · Leon'S Fecal Sanitary Tub Mfg. · Jan 1982
THE CHICAGO GULLET
K813132 · Universal Prosthetics, Inc. · Jan 1982
EHTOX GASTRIC LAVAGE KIT #2050 & #2070
K812648 · Ethox Corp. · Sep 1981
CARTMILL/BARRY FEEDING TUBE
K812427 · Impra, Inc. · Sep 1981
THE KEOFEED STOMACH TUBE
K812507 · Hedeco · Sep 1981
K813169 · CELESTIN PULSION ESOPHOGEAL PROSTHESIS
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