Cleared Traditional

K832672 - FOUR LUMEN BLAKEMORE TUBE

K832672 is the FDA 510(k) clearance for FOUR LUMEN BLAKEMORE TUBE by Inmed Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K832672 · Inmed Corp. · Gastroenterology & Urology device
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Sep 1983
Decision
34d
Days
Class 2
Risk

K832672 is an FDA 510(k) clearance for the FOUR LUMEN BLAKEMORE TUBE. 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 September 12, 1983 after a review of 34 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 K832672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1983
Decision Date September 12, 1983
Days to Decision 34 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
96d faster than avg
Panel avg: 130d · This submission: 34d
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 K832672.
LEIDER FEEDING TUBE W/HYDROMER LUBR
K833293 · Biosearch Medical Products, Inc. · Oct 1983
SHERIDAN/LEVI-A-SUMP
K832196 · Sheridan Catheter Corp. · Oct 1983
ENTERNAL FEEDING TUBE
K832293 · Concept, Inc. · Sep 1983
FEEDING TUBE PLACEMENT STYLET
K831840 · Biosearch Medical Products, Inc. · Aug 1983
STOMACH TUBE LEVIN TUBE
K831974 · Medline Industries, Inc. · Jul 1983
BROOKS SCLEROTHERAPY CUFF
K823475 · Inmed Corp. · Jul 1983