Cleared Traditional

K981125 - MEDCOMP TESIO CATHETER

K981125 is an FDA 510(k) clearance for MEDCOMP TESIO CATHETER, manufactured by Medical Components, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K981125 · Medical Components, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
336d
Days
Class 2
Risk

K981125 is an FDA 510(k) clearance for the MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on February 26, 1999 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Components, Inc. devices

FDA 510(k) Submission Details - K981125

510(k) Number K981125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1998
Decision Date February 26, 1999
Days to Decision 336 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 130d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSD Device Classification - Class 2, Special Controls

Product Code MSD Catheter, Hemodialysis, Implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - MSD Catheter, Hemodialysis, Implanted

All 63
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K981125.
MEDCOMP ULTRA-FLOW CATHETER
K003207 · Medical Components, Inc. · Jun 2001
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR
K010567 · C.R. Bard, Inc. · Mar 2001
MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY
K982326 · Boston Scientific Corp · Jul 1999
MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY
K982333 · Cook, Inc. · Feb 1999
MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS
K981365 · Sherwood Medical Co. · Nov 1998
VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER
K981994 · C.R. Bard, Inc. · Sep 1998