Cleared Traditional

K843866 - HEMODIALYSATE SOLUTIONS

K843866 is an FDA 510(k) clearance for HEMODIALYSATE SOLUTIONS, manufactured by Bicarbolyte Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K843866 · Bicarbolyte Corp. · Gastroenterology & Urology device
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Jan 1985
Decision
99d
Days
Class 2
Risk

K843866 is an FDA 510(k) clearance for the HEMODIALYSATE SOLUTIONS. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Bicarbolyte Corp. (Charlottesville, US). The FDA issued a Cleared decision on January 9, 1985 after a review of 99 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K843866

510(k) Number K843866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1984
Decision Date January 09, 1985
Days to Decision 99 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
32d faster than avg
Panel avg: 131d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPO Device Classification - Class 2, Special Controls

Product Code KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)
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 - KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)

All 96
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K843866.
HOSPAL DIALYSATE FOR C.A.V.H.D.
K872857 · Delmed, Inc. · Oct 1987
HOSPAL DIALYSATE FOR CAVHD
K861156 · Hospal Medical Corp. · Sep 1986
ULTRACLONE 05-100 GUINEA PIG RBC
K854206 · Earl-Clay Laboratories, Inc. · Oct 1985
CENTRALYTE BICARBONATE CONCENTRATE
K821304 · Erika, Inc. · May 1982
NATURALYTE BICARBONATE DIALYSATE CONCEN.
K810925 · Erika, Inc. · Apr 1981
DIALYSATE CONCENTRATE FOR HEMODIALYSIS
K810280 · Cobe Laboratories, Inc. · Feb 1981