Cleared Traditional

RENAPAK CONCENTRATE MIXING SYS. (K840182) - FDA 510(k) Clearance

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

K840182 · Renal Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1984
Decision
106d
Days
Class 2
Risk

K840182 is an FDA 510(k) clearance for the RENAPAK CONCENTRATE MIXING SYS.. Classified as System, Dialysate Delivery, Central Multiple Patient (product code FKQ), Class II - Special Controls.

Submitted by Renal Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1984 after a review of 106 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.

View all Renal Systems, Inc. devices

Submission Details

510(k) Number K840182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1984
Decision Date May 02, 1984
Days to Decision 106 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
24d faster than avg
Panel avg: 130d · This submission: 106d
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 K840182.
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