Cleared Traditional

K843014 - FRESENIUS HAEMODIALYSIS A2008

K843014 is the FDA 510(k) clearance for FRESENIUS HAEMODIALYSIS A2008 by Seratronics, Inc.. It is a Class 2 Hematology device (product code KDI) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K843014 · Seratronics, Inc. · Hematology device
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Oct 1984
Decision
79d
Days
Class 2
Risk

K843014 is an FDA 510(k) clearance for the FRESENIUS HAEMODIALYSIS A2008. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Seratronics, Inc. (Concord, US). The FDA issued a Cleared decision on October 18, 1984 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 876.5860 - the FDA hematology 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 Seratronics, Inc. devices

Submission Details

510(k) Number K843014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1984
Decision Date October 18, 1984
Days to Decision 79 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 113d · This submission: 79d
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 Hematology devices follow this clearance model.

Regulatory Peers - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 199
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K843014.
RENAFLO HEMOCONCENTRATOR
K844790 · Renal Systems, Inc. · May 1985
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L
K850866 · Erika, Inc. · Apr 1985
AMER. BENTLEY CONTINU-BLOOD PROCESSOR-
K841585 · American Bentley · Oct 1984
HOSPAL BIOSPAL SCU/CAVH KIT
K841152 · Hospal Medical Corp. · Jul 1984
CENTRY 2000 DIALYSIS CONTROL UNIT
K840680 · Cobe Laboratories, Inc. · Apr 1984
BLOOD CONCENTRATOR 140
K840543 · Gambro, Inc. · Mar 1984