Cleared Traditional

K922005 - GRANULYTE DIALYSATE CONCENTRATE

K922005 is an FDA 510(k) clearance for GRANULYTE DIALYSATE CONCENTRATE, manufactured by Fresenius USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 700-day FDA review.

K922005 · Fresenius USA, Inc. · Gastroenterology & Urology device
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Mar 1994
Decision
700d
Days
Class 2
Risk

K922005 is an FDA 510(k) clearance for the GRANULYTE DIALYSATE CONCENTRATE. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on March 30, 1994 after a review of 700 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Fresenius USA, Inc. devices

FDA 510(k) Submission Details - K922005

510(k) Number K922005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1992
Decision Date March 30, 1994
Days to Decision 700 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
570d slower than avg
Panel avg: 130d · This submission: 700d
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 59
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K922005.
DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
K011368 · Gambro Renal Products · Aug 2001
FRESENIUS DIALYSATE ACID CONCENTRATE
K922088 · Fresenius USA, Inc. · Oct 1994
HEMODIALYSIS BATH
K922990 · Medi-Tech, Inc. · Sep 1994
GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING
K911459 · Fresenius USA, Inc. · Jul 1991
PREMIXED DIALYSATE FOR HEMODIAFILTRATION
K910270 · Baxter Healthcare Corp · Apr 1991
ACETATE CONCENTRATES FOR HEMODIALYSIS
K905021 · Medical Components, Inc. · Mar 1991