Cleared Special

K991431 - 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERI...

K991431 is an FDA 510(k) clearance for 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERI..., manufactured by Arrow Intl., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MPB cleared through the Special 510(k) pathway after a 30-day FDA review.

K991431 · Arrow Intl., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
30d
Days
Class 2
Risk

K991431 is an FDA 510(k) clearance for the 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT. Classified as Catheter, Hemodialysis, Non-implanted (product code MPB), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on May 26, 1999 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K991431

510(k) Number K991431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1999
Decision Date May 26, 1999
Days to Decision 30 days
Submission Type Special
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
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MPB Device Classification - Class 2, Special Controls

Product Code MPB Catheter, Hemodialysis, Non-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 - MPB Catheter, Hemodialysis, Non-implanted

All 28
Devices cleared under the same product code (MPB) and FDA review panel - the closest regulatory comparables to K991431.
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K983511 · Medical Components, Inc. · Jun 1999
PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
K984022 · Arrow Intl., Inc. · May 1999
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K974236 · Medical Components, Inc. · Apr 1999
NIAGARA DUAL LUMEN CATHETER
K965178 · Vas-Cath, Inc. · Aug 1997