Cleared Traditional

K844663 - ASAHI NEW PAN-SERIES HEMOFILTERS

K844663 is the FDA 510(k) clearance for ASAHI NEW PAN-SERIES HEMOFILTERS by Asahi Medical Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K844663 · Asahi Medical Co., Ltd. · Gastroenterology & Urology device
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Jan 1985
Decision
49d
Days
Class 2
Risk

K844663 is an FDA 510(k) clearance for the ASAHI NEW PAN-SERIES HEMOFILTERS. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Asahi Medical Co., Ltd. (Washington, US). The FDA issued a Cleared decision on January 18, 1985 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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: 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 Asahi Medical Co., Ltd. devices

Submission Details

510(k) Number K844663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1984
Decision Date January 18, 1985
Days to Decision 49 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 130d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 199
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K844663.
DIMENSION TOTAL HIP PROSTHESIS
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K841152 · Hospal Medical Corp. · Jul 1984
CENTRY 2000 DIALYSIS CONTROL UNIT
K840680 · Cobe Laboratories, Inc. · Apr 1984