Cleared Traditional

K832859 - FOAM HELMET - USE W/ESOPHAGEAL TAMPONA

K832859 is an FDA 510(k) clearance for FOAM HELMET - USE W/ESOPHAGEAL TAMPONA, 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 83-day FDA review.

K832859 · Inmed Corp. · Gastroenterology & Urology device
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Nov 1983
Decision
83d
Days
Class 2
Risk

K832859 is an FDA 510(k) clearance for the FOAM HELMET - USE W/ESOPHAGEAL TAMPONA. 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 November 14, 1983 after a review of 83 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

FDA 510(k) Submission Details - K832859

510(k) Number K832859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1983
Decision Date November 14, 1983
Days to Decision 83 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
48d faster than avg
Panel avg: 131d · This submission: 83d
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 514
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K832859.
NEEDLE CATHETER JEJUNOSTOMY KIT
K833513 · Biosearch Medical Products, Inc. · Nov 1983
FEEDING TUBE
K833591 · Medovations, Inc. · Nov 1983
ENTRI FLEX FEEDING TUBE
K833621 · Biosearch Medical Products, Inc. · Nov 1983
FLEXIFLO ENTERAL FEEDING TUBE
K832966 · Abbott Laboratories · Oct 1983
LEIDER FEEDING TUBE W/HYDROMER LUBR
K833293 · Biosearch Medical Products, Inc. · Oct 1983
GASTRIC SUMP TUBES
K833054 · Medovations, Inc. · Oct 1983