Cleared Traditional

K885017 - HEMOSORBA CH-500, CH-350 AND CH-180

K885017 is an FDA 510(k) clearance for HEMOSORBA CH-500, manufactured by Asahi Medical Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FLD cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K885017 · Asahi Medical Co., Ltd. · Gastroenterology & Urology device
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Mar 1989
Decision
102d
Days
Class 2
Risk

K885017 is an FDA 510(k) clearance for the HEMOSORBA CH-500, CH-350 AND CH-180. Classified as Apparatus, Hemoperfusion, Sorbent (product code FLD), Class II - Special Controls.

Submitted by Asahi Medical Co., Ltd. (Washington, US). The FDA issued a Cleared decision on March 17, 1989 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5870 - 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 - K885017

510(k) Number K885017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1988
Decision Date March 17, 1989
Days to Decision 102 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
29d faster than avg
Panel avg: 131d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLD Device Classification - Class 2, Special Controls

Product Code FLD Apparatus, Hemoperfusion, Sorbent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5870
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 - FLD Apparatus, Hemoperfusion, Sorbent

All 10
Devices cleared under the same product code (FLD) and FDA review panel - the closest regulatory comparables to K885017.
BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK
K984546 · Hemocleanse, Inc. · Aug 1999
AHCS HEMOPERFUSION SYSTEM
K971015 · American Health Care Systems, Inc. · Oct 1997
BIOLOGIC-DT SYSTEM
K953751 · Hemocleanse, Inc. · Feb 1996
GAMBRO ADSORBA 150C
K873643 · Gambro, Inc. · Dec 1987
HEMOPERFUSION SYSTEM TP-400
K840532 · Extracorporeal Medical Specialities, Inc. · May 1984
HEMOPERFUSION SYSTEM TP-400
K831029 · Extracorporeal Medical Specialities, Inc. · Aug 1983