Cleared Traditional

K831868 - DOBBHOFF FEEDING TUBE W/HYDROMER LUB

K831868 is the FDA 510(k) clearance for DOBBHOFF FEEDING TUBE W/HYDROMER LUB by Biosearch Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K831868 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1983
Decision
32d
Days
Class 2
Risk

K831868 is an FDA 510(k) clearance for the DOBBHOFF FEEDING TUBE W/HYDROMER LUB. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on July 12, 1983 after a review of 32 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 Biosearch Medical Products, Inc. devices

Submission Details

510(k) Number K831868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1983
Decision Date July 12, 1983
Days to Decision 32 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
98d faster than avg
Panel avg: 130d · This submission: 32d
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 257
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K831868.
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
ARGYLE MADEN SILICONE GASTROSTOMY TUBE
K830794 · Sherwood Medical Co. · May 1983
ENTERAL PUMP SET
K831167 · Biosearch Medical Products, Inc. · May 1983
ENTERAL DELIVERY SET
K831168 · Biosearch Medical Products, Inc. · May 1983