Cleared Traditional

K994105 - HEMO-FLOW DOUBLE LUMEN CATHETER

K994105 is an FDA 510(k) clearance for HEMO-FLOW DOUBLE LUMEN 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 667-day FDA review.

K994105 · Medical Components, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
667d
Days
Class 2
Risk

K994105 is an FDA 510(k) clearance for the HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40. 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 October 3, 2001 after a review of 667 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Medical Components, Inc. devices

FDA 510(k) Submission Details - K994105

510(k) Number K994105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1999
Decision Date October 03, 2001
Days to Decision 667 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
537d slower than avg
Panel avg: 130d · This submission: 667d
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 K994105.
MEDCOMP ASH SPLIT-CATH II
K020465 · Medcomp · May 2002
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K010306 · Medcomp · Oct 2001
VAXCEL DIALYSIS CATHETER
K012365 · Boston Scientific Corp · Aug 2001
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