Cleared Traditional

K992904 - MINI-PORT

K992904 is the FDA 510(k) clearance for MINI-PORT by Taut, Inc.. It is a Class 1 General & Plastic Surgery device (product code GBW) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K992904 · Taut, Inc. · General & Plastic Surgery device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Oct 1999

Decision

36d

Days

Class 1

Risk

K992904 is an FDA 510(k) clearance for the MINI-PORT. Classified as Catheter, Peritoneal (product code GBW), Class I - General Controls.

Submitted by Taut, Inc. (Geneva, US). The FDA issued a Cleared decision on October 5, 1999 after a review of 36 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 Taut, Inc. devices

Submission Details

510(k) Number	K992904 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 30, 1999
Decision Date	October 05, 1999
Days to Decision	36 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

79d faster than avg

Panel avg: 115d · This submission: 36d

Pathway characteristics

Predicate-based equivalence.

Device Classification

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

Devices cleared under the same product code (GBW) and FDA review panel - the closest regulatory comparables to K992904.

MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER

K960426 · Medical Components, Inc. · Mar 1996

ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER

K933510 · Sherwood Medical Co. · Feb 1994

NELSON-JUNG PLEURAL CATH

K854812 · Research Medical, Inc. · Feb 1986

ARROW PERITONEAL LAVAGE CATHERIZATION K

K811627 · Arrow Intl., Inc. · Aug 1981

PERCUTANEOUS DRAINING CATHETER

K811378 · Medi-Tech, Inc. · Jun 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K992904

Taut, Inc.

Geneva, IL · US

RONALD KENSETH

Regulatory profile

16 submissions 16 cleared

100% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active