Cleared Traditional

K983720 - ASAHI AM-BIO SERIES DIALYZERS (WET MODE...

K983720 is the FDA 510(k) clearance for ASAHI AM-BIO SERIES DIALYZERS (WET MODE... by Asahi Medical Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code MSE) cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K983720 · Asahi Medical Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
208d
Days
Class 2
Risk

K983720 is an FDA 510(k) clearance for the ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM.... Classified as Hemodialyzer, Re-use, Low Flux (product code MSE), Class II - Special Controls.

Submitted by Asahi Medical Co., Ltd. (Rockville, US). The FDA issued a Cleared decision on May 17, 1999 after a review of 208 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Asahi Medical Co., Ltd. devices

Submission Details

510(k) Number K983720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1998
Decision Date May 17, 1999
Days to Decision 208 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 130d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSE Hemodialyzer, Re-use, Low Flux
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - MSE Hemodialyzer, Re-use, Low Flux

Devices cleared under the same product code (MSE) and FDA review panel - the closest regulatory comparables to K983720.
PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
K001685 · Baxter Healthcare Corp · Nov 2000
FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
K970700 · Fresenius USA, Inc. · Sep 1998
95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
K974090 · Fresenius Medical Care North America · Aug 1998
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
K970654 · Baxter Healthcare Corp · Nov 1997
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)
K970661 · Baxter Healthcare Corp · Nov 1997