Cleared Traditional

K802466 - DISSCAP HOLLOW FIBER DIALYZER

K802466 is an FDA 510(k) clearance for DISSCAP HOLLOW FIBER DIALYZER, manufactured by Hospal Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K802466 · Hospal Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1980
Decision
35d
Days
Class 2
Risk

K802466 is an FDA 510(k) clearance for the DISSCAP HOLLOW FIBER DIALYZER. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Hospal Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 35 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

FDA 510(k) Submission Details - K802466

510(k) Number K802466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1980
Decision Date November 12, 1980
Days to Decision 35 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
96d faster than avg
Panel avg: 131d · This submission: 35d
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 K802466.
NEPHROSS DIALYZER
K802114 · Organon Teknika Corp. · Dec 1980
CLIRANS TH13 HOLLOW FIBER DIALYZER
K802122 · Terumo America, Inc. · Dec 1980
CLIRANS TH10 HOLLOW FIBER DIALYZER
K802441 · Terumo America, Inc. · Dec 1980
RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D.
K801825 · Renal Systems, Inc. · Sep 1980
RENAFLO HOLLOW FIBER DIALYZERS #MP 140
K801826 · Renal Systems, Inc. · Sep 1980
RENAFLO HOLLOW FIBER DIALYZER #100.1
K801827 · Renal Systems, Inc. · Sep 1980