Cleared Traditional

K855212 - ASAHI AM SERIES DIALYZERS

K855212 is the FDA 510(k) clearance for ASAHI AM SERIES DIALYZERS by Advocacy International, Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FJI) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K855212 · Advocacy International, Ltd. · Gastroenterology & Urology device
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Jan 1986
Decision
22d
Days
Class 2
Risk

K855212 is an FDA 510(k) clearance for the ASAHI AM SERIES DIALYZERS. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Advocacy International, Ltd. (Washington, US). The FDA issued a Cleared decision on January 21, 1986 after a review of 22 days - a notably fast clearance 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: 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 Advocacy International, Ltd. devices

Submission Details

510(k) Number K855212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1985
Decision Date January 21, 1986
Days to Decision 22 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
108d faster than avg
Panel avg: 130d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 85
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K855212.
ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7
K861536 · National Medical Care, Medical Products Div., Inc. · Jul 1986
ADVANCED PERFORM HOLLOW FIBER DIALYZER, 019752-5
K861537 · National Medical Care, Medical Products Div., Inc. · Jul 1986
ADVANCED PERFORMANCE HOLLOW FIBER DIALYZER
K861916 · National Medical Care, Medical Products Div., Inc. · Jul 1986
CLIRANS TAF HOLLOW FIBER DIALYZER
K854280 · Terumo Medical Corp. · Dec 1985
DIALYZER, CAPILLARY, HOLLOW FIBER
K853591 · Organon Teknika Corp. · Sep 1985
DISSCAP 110 DIALYZER
K851380 · Hospal Medical Corp. · Apr 1985