Cleared Traditional

K813169 - CELESTIN PULSION ESOPHOGEAL PROSTHESIS

K813169 is the FDA 510(k) clearance for CELESTIN PULSION ESOPHOGEAL PROSTHESIS by Inmed Corp.. It is a Class 2 Gastroenterology & Urology device (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.

View all Inmed Corp. devices

Submission Details

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

109d faster than avg

Panel avg: 130d · This submission: 21d

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 268

Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K813169.

AM. PH. STERILE FEEDING TUBE

K820420 · American Pharmaseal Div. Ahsc · Mar 1982

ARGYLE PVC FEEDING TUBE

K820441 · Sherwood Medical Co. · Mar 1982

ARGYLE INDWELL FEEDING TUBE

K820442 · Sherwood Medical Co. · Mar 1982

ENTER-A1 ENTERIC FEEDING TUBE

K812279 · Medi-Tech, Inc. · Aug 1981

ENTRI ENTERNAL FEEDING SET

K811683 · Biosearch Medical Products, Inc. · Jul 1981

ARROW NEEDLE-CATHETER JEJUNOSTOMY KIT

K810979 · Arrow Intl., Inc. · Jun 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K813169

Inmed Corp.

Mchenry, IL · US

Regulatory profile

32 submissions 32 cleared

100% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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