Cleared Traditional

K991512 - ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X

K991512 is an FDA 510(k) clearance for ASAHI AM-R-SERIES DIALYZERS (MODIFIED), manufactured by Asahi Medical Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K991512 · Asahi Medical Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
90d
Days
Class 2
Risk

K991512 is an FDA 510(k) clearance for the ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Asahi Medical Co., Ltd. (Rockville, US). The FDA issued a Cleared decision on July 29, 1999 after a review of 90 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K991512

510(k) Number K991512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1999
Decision Date July 29, 1999
Days to Decision 90 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
41d faster than avg
Panel avg: 131d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJI Device Classification - Class 2, Special Controls

Product Code FJI Dialyzer, Capillary, Hollow Fiber
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 - FJI Dialyzer, Capillary, Hollow Fiber

All 117
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K991512.
IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS
K991908 · Idemsa · Apr 2000
A-15 HEMODIALYZER
K992594 · Althin Medical AB · Sep 1999
A-18 HEMODIALYZER
K992565 · Althin Medical AB · Sep 1999
DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111
K990159 · Dynamic Technology Corp. · Apr 1999
CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER
K982337 · Haidylena Medical Egypt · Dec 1998
ULTRACON ULTRAFILTRATOR
K981253 · Interpore Intl. · Dec 1998