Cleared Traditional

K840182 - RENAPAK CONCENTRATE MIXING SYS.

K840182 is the FDA 510(k) clearance for RENAPAK CONCENTRATE MIXING SYS. by Renal Systems, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FKQ) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

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
Combination Product No
PCCP Authorized No
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 31
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K840182.
DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD
K843963 · Renal Systems, Inc. · Jan 1985
PACKETS FOR THE PREP OF DIALYSATES &
K842154 · Organon Teknika Corp. · Jul 1984
CONCENTRATE CONDUCTIVITY METER
K841543 · Renal Systems, Inc. · May 1984
BIOSPAL 3000S
K840811 · Hospal Medical Corp. · Apr 1984
BIOSPAL 2400S
K840812 · Hospal Medical Corp. · Apr 1984
BIOSPAL 1200S
K840813 · Hospal Medical Corp. · Apr 1984