Cleared Traditional

K832293 - ENTERNAL FEEDING TUBE

K832293 is an FDA 510(k) clearance for ENTERNAL FEEDING TUBE, manufactured by Concept, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K832293 · Concept, Inc. · Gastroenterology & Urology device

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Sep 1983

Decision

61d

Days

Class 2

Risk

K832293 is an FDA 510(k) clearance for the ENTERNAL FEEDING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Concept, Inc. (Walker, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 61 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 Concept, Inc. devices

FDA 510(k) Submission Details - K832293

510(k) Number	K832293 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 13, 1983
Decision Date	September 12, 1983
Days to Decision	61 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

69d faster than avg

Panel avg: 130d · This submission: 61d

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 300

Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K832293.

LEIDER FEEDING TUBE W/HYDROMER LUBR

K833293 · Biosearch Medical Products, Inc. · Oct 1983

GASTRIC SUMP TUBES

K833054 · Medovations, Inc. · Oct 1983

SHERIDAN/LEVI-A-SUMP

K832196 · Sheridan Catheter Corp. · Oct 1983

FOUR LUMEN BLAKEMORE TUBE

K832672 · Inmed Corp. · Sep 1983

AXIOM FEEDING GASTRO TUBE

K831823 · Axiom Medical, Inc. · Aug 1983

FEEDING TUBE PLACEMENT STYLET

K831840 · Biosearch Medical Products, Inc. · Aug 1983

FDA 510(k) Resources - Gastroenterology & Urology

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

Manufacturer of K832293

Concept, Inc.

Walker, MI · US

Regulatory profile

83 submissions 82 cleared

99% clearance rate · Active in Gastroenterology & Urology

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

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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