Cleared Traditional

K834589 - BIOSPAL 1800S

K834589 is the FDA 510(k) clearance for BIOSPAL 1800S by Hospal Medical Corp.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K834589 · Hospal Medical Corp. · Gastroenterology & Urology device
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Feb 1984
Decision
37d
Days
Class 2
Risk

K834589 is an FDA 510(k) clearance for the BIOSPAL (R) 1800S. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Hospal Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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 K834589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1983
Decision Date February 04, 1984
Days to Decision 37 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
93d faster than avg
Panel avg: 130d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 187
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K834589.
CENTRY 2000 DIALYSIS CONTROL UNIT
K840680 · Cobe Laboratories, Inc. · Apr 1984
BLOOD CONCENTRATOR 140
K840543 · Gambro, Inc. · Mar 1984
HEMOFILTRATION SYSTEM
K831784 · Gambro, Inc. · Feb 1984
ULTRAFILTRATION CONTROLLER
K832547 · Extracorporeal Medical Specialities, Inc. · Jan 1984
BIOSPAL 3000 S
K832645 · Hospal Medical Corp. · Sep 1983
BIOSPAL 1200S
K832659 · Hospal Medical Corp. · Sep 1983