Cleared Traditional

K932295 - NON-BALLOON REPLACEMENT GASTROSTOMY KIT

K932295 is the FDA 510(k) clearance for NON-BALLOON REPLACEMENT GASTROSTOMY KIT 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 485-day FDA review.

K932295 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
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Sep 1994
Decision
485d
Days
Class 2
Risk

K932295 is an FDA 510(k) clearance for the NON-BALLOON REPLACEMENT GASTROSTOMY KIT. 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 September 8, 1994 after a review of 485 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Biosearch Medical Products, Inc. devices

Submission Details

510(k) Number K932295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1993
Decision Date September 08, 1994
Days to Decision 485 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
355d slower than avg
Panel avg: 130d · This submission: 485d
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 K932295.
VANSONNENBERG GASTROSTOMY CATHETER
K924850 · Boston Scientific Corp · Dec 1994
KLEIN RECTAL TAMPNADE BALLOON
K933842 · Cook Urological, Inc. · Sep 1994
GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS
K935198 · Lake Region Mfg., Inc. · Sep 1994
BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER
K935045 · Biosearch Medical Products, Inc. · Aug 1994
LOW PROFILE PASSPORT PUSH & PULL KITS & PEG TUBE
K920579 · Wilson-Cook Medical, Inc. · Jul 1994
ENTEROCLYSIS TUBE
K923002 · Biosearch Medical Products, Inc. · Jun 1994