Cleared Traditional

K844222 - BIOSEARCH GLASER PEG PERCUTANEOUS ENDOS...

K844222 is the FDA 510(k) clearance for BIOSEARCH GLASER PEG PERCUTANEOUS ENDOS... 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 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

Submission Details

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
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 257
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K844222.
KANGAROO NASOGASTRIC FEEDING TUBE
K843567 · Chesebrough-Pond'S U.S.A. Co. · Feb 1985
ENTRON ENTERAL FEEDING BAG
K850134 · Biosearch Medical Products, Inc. · Feb 1985
KANGAROO ACCESS II ENTERAL FEEDING CONTAINER
K844789 · Chesebrough-Pond'S U.S.A. Co. · Jan 1985
DAVOL GAUDERER-PONSKY PERCUTAN-ENDOSCOP
K843305 · C.R. Bard, Inc. · Oct 1984
IVAC KEOFEED HYDROPHILIC FEEDING TUBE
K842589 · Y · Aug 1984
JEJUNOSTOMY SET FOR TUBE FEEDING
K841428 · Burron Medical Products, Inc. · Jul 1984