Cleared Traditional

K863592 - DISSCAP 80E

K863592 is the FDA 510(k) clearance for DISSCAP 80E by Hospal Medical Corp.. It is a Class 2 Gastroenterology & Urology device (product code FJI) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K863592 · Hospal Medical Corp. · Gastroenterology & Urology device
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Sep 1986
Decision
10d
Days
Class 2
Risk

K863592 is an FDA 510(k) clearance for the DISSCAP 80E, 110E, 140E, 160E. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Hospal Medical Corp. (East Brunswick, US). The FDA issued a Cleared decision on September 25, 1986 after a review of 10 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 Hospal Medical Corp. devices

Submission Details

510(k) Number K863592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1986
Decision Date September 25, 1986
Days to Decision 10 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 130d · This submission: 10d
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 84
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K863592.
CAPILLARY FLOW DIALYZERS
K870169 · Travenol Laboratories, S.A. · Apr 1987
CAPILLARY FLOW HOLLOW FIBER DIALYZERS
K863044 · National Medical Care, Medical Products Div., Inc. · Mar 1987
COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS
K864831 · Cobe Laboratories, Inc. · Mar 1987
TORAY FILTRYZER DIALYZER, B1-2.0.
K862693 · National Medical Care, Medical Products Div., Inc. · Jul 1986
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