Cleared Traditional

K782057 - CATHETER

K782057 is the FDA 510(k) clearance for CATHETER by Dravon Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJS) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K782057 · Dravon Medical, Inc. · Gastroenterology & Urology device
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Feb 1979
Decision
82d
Days
Class 2
Risk

K782057 is an FDA 510(k) clearance for the CATHETER, RADIOPAQUE TENCKHOFF. Classified as Catheter, Peritoneal, Long-term Indwelling (product code FJS), Class II - Special Controls.

Submitted by Dravon Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 27, 1979 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - 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 Dravon Medical, Inc. devices

Submission Details

510(k) Number K782057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1978
Decision Date February 27, 1979
Days to Decision 82 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 130d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJS Catheter, Peritoneal, Long-term Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 - FJS Catheter, Peritoneal, Long-term Indwelling

All 14
Devices cleared under the same product code (FJS) and FDA review panel - the closest regulatory comparables to K782057.
CUFF MATERIAL ON PEDIATRIC SIZE CATH.
K812718 · Quinton, Inc. · Oct 1981
TENCKHOFF PERITONEAL CATHETERS
K812607 · Quinton, Inc. · Oct 1981
BETA-CAP II
K801679 · Quinton, Inc. · Oct 1980
BETA CAP SYSTEM
K780449 · Quinton, Inc. · May 1978
SHADOW-CATHS
K780643 · Quinton, Inc. · Apr 1978
BETA-CAP
K771420 · Quinton, Inc. · Nov 1977