Cleared Traditional

DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD (K843963) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K843963 · Renal Systems, Inc. · Gastroenterology & Urology device
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Jan 1985
Decision
88d
Days
Class 2
Risk

K843963 is an FDA 510(k) clearance for the DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD. Classified as System, Dialysate Delivery, Central Multiple Patient (product code FKQ), Class II - Special Controls.

Submitted by Renal Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 7, 1985 after a review of 88 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 Renal Systems, Inc. devices

Submission Details

510(k) Number K843963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1984
Decision Date January 07, 1985
Days to Decision 88 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
42d faster than avg
Panel avg: 130d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKQ System, Dialysate Delivery, Central Multiple Patient
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 - FKQ System, Dialysate Delivery, Central Multiple Patient

All 60
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K843963.
ST FAMILY OF HOLLOW FIBER DIALYZERS
K844756 · Travenol Laboratories, S.A. · Jan 1985
GAMMA STERIL. CAPILLARY FLOW DIALY-G15
K832663 · Travenol Laboratories, S.A. · Sep 1983
GAMMA STERILIZED CAPILLARY FLOW DIALYZ
K831940 · Travenol Laboratories, S.A. · Aug 1983
ALTERNATE STERILIZ. FOR CELLULOSE ACET
K810315 · Cordis Corp. · Mar 1981
DIALYZING FLUIDE DELIVERY SYSTEM
K780081 · Travenol Laboratories, S.A. · Mar 1978
PRESSURE MODULE 5M1247
K771375 · Travenol Laboratories, S.A. · Sep 1977