Cleared Traditional

K984022 - PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHER...

K984022 is an FDA 510(k) clearance for PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHER..., manufactured by Arrow Intl., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MPB cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K984022 · Arrow Intl., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
187d
Days
Class 2
Risk

K984022 is an FDA 510(k) clearance for the PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION 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 18, 1999 after a review of 187 days - an extended review cycle.

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. Standard predicate reliance. 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K984022

510(k) Number K984022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1998
Decision Date May 18, 1999
Days to Decision 187 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
57d slower than avg
Panel avg: 130d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K984022.
11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT
K980438 · Medical Components, Inc. · Jun 1999
SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH
K983511 · Medical Components, Inc. · Jun 1999
14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT
K991431 · Arrow Intl., Inc. · May 1999
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NIAGARA DUAL LUMEN CATHETER
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KENDALL DUAL LUMEN CATHETER
K963446 · Kendall Healthcare Products Co. Div.Of Tyco Health · Mar 1997