Cleared Traditional

K894119 - MADEGOM LTDA. PENROSE DRAIN TUBING

K894119 is an FDA 510(k) clearance for MADEGOM LTDA. PENROSE DRAIN TUBING, manufactured by Madegom. The device is a Class 1 General & Plastic Surgery device with product code GBW cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K894119 · Madegom · General & Plastic Surgery device
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Aug 1989
Decision
67d
Days
Class 1
Risk

K894119 is an FDA 510(k) clearance for the MADEGOM LTDA. PENROSE DRAIN TUBING. Classified as Catheter, Peritoneal (product code GBW), Class I - General Controls.

Submitted by Madegom (Chile, CL). The FDA issued a Cleared decision on August 18, 1989 after a review of 67 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 Madegom devices

FDA 510(k) Submission Details - K894119

510(k) Number K894119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1989
Decision Date August 18, 1989
Days to Decision 67 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

GBW Device Classification - Class 1, General Controls

Product Code GBW Catheter, Peritoneal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GBW Catheter, Peritoneal

All 14
Devices cleared under the same product code (GBW) and FDA review panel - the closest regulatory comparables to K894119.
MEDIASTINAL SILICONE DRAINS
K942709 · Sil-Med Corp. · Jan 1996
ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER
K933510 · Sherwood Medical Co. · Feb 1994
BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO
K926477 · Core Dynamics, Inc. · Nov 1993
NELSON-JUNG PLEURAL CATH
K854812 · Research Medical, Inc. · Feb 1986
DERBYSHIRE DRAIN
K843575 · Sil-Med Corp. · Oct 1984
FLAT DRAIN
K813063 · Sil-Med Corp. · Dec 1981