Cleared Traditional

K983618 - DRI-SATE MIXER FOR PREPARATION OF ACIDI...

K983618 is an FDA 510(k) clearance for DRI-SATE MIXER FOR PREPARATION OF ACIDI..., manufactured by Rockwell Medical Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K983618 · Rockwell Medical Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
294d
Days
Class 2
Risk

K983618 is an FDA 510(k) clearance for the DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Rockwell Medical Technologies, Inc. (Wixom, US). The FDA issued a Cleared decision on August 5, 1999 after a review of 294 days - an extended review 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: 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 Rockwell Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K983618

510(k) Number K983618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1998
Decision Date August 05, 1999
Days to Decision 294 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 130d · This submission: 294d
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 53
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K983618.
NXSTAGE PUREFLOW SOLUTION
K033386 · Nxstage Medical, Inc. · Nov 2003
NXSTAGE PREMIXED DIALYSATE
K022913 · Nxstage Medical, Inc. · Oct 2002
NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100
K013655 · Nxstage Medical, Inc. · Feb 2002
FRESENIUS DIALYSATE ACID CONCENTRATE
K922088 · Fresenius USA, Inc. · Oct 1994
HEMODIALYSIS BATH
K922990 · Medi-Tech, Inc. · Sep 1994
GRANULYTE DIALYSATE CONCENTRATE
K922005 · Fresenius USA, Inc. · Mar 1994