Cleared Traditional

K844222 - BIOSEARCH GLASER PEG PERCUTANEOUS ENDOSCOPIC GASTR

K844222 is an FDA 510(k) clearance for BIOSEARCH GLASER PEG PERCUTANEOUS ENDOS..., manufactured by Biosearch Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K844222 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
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Dec 1984
Decision
34d
Days
Class 2
Risk

K844222 is an FDA 510(k) clearance for the BIOSEARCH GLASER PEG PERCUTANEOUS ENDOSCOPIC GASTR. 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 December 5, 1984 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 Biosearch Medical Products, Inc. devices

FDA 510(k) Submission Details - K844222

510(k) Number K844222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1984
Decision Date December 05, 1984
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
97d faster than avg
Panel avg: 131d · This submission: 34d
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 469
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K844222.
ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403
K844203 · Exco, Inc. · Jan 1985
KANGAROO ACCESS II ENTERAL FEEDING CONTAINER
K844789 · Chesebrough-Pond'S U.S.A. Co. · Jan 1985
FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI
K844174 · Exco, Inc. · Dec 1984
DAVOL GAUDERER-PONSKY PERCUTAN-ENDOSCOP
K843305 · C.R. Bard, Inc. · Oct 1984
GAUDERER GASTROSTOMY BUTTON
K843392 · American V. Mueller · Oct 1984
MIC GASTROSTOMY TUBE
K842076 · Medical Innovations Corp. · Aug 1984