Cleared Special

K993212 - DRYASOL ACID CONCENTRATE MIX

K993212 is an FDA 510(k) clearance for DRYASOL ACID CONCENTRATE MIX, manufactured by Diasol, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Special 510(k) pathway after a 28-day FDA review.

K993212 · Diasol, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
28d
Days
Class 2
Risk

K993212 is an FDA 510(k) clearance for the DRYASOL ACID CONCENTRATE MIX. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Diasol, Inc. (North Hollywood, US). The FDA issued a Cleared decision on October 22, 1999 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Diasol, Inc. devices

FDA 510(k) Submission Details - K993212

510(k) Number K993212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1999
Decision Date October 22, 1999
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K993212.
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