Cleared Traditional

K922088 - FRESENIUS DIALYSATE ACID CONCENTRATE (FDA 510(k) Clearance)

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

K922088 · Fresenius USA, Inc. · Gastroenterology & Urology device
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Oct 1994
Decision
896d
Days
Class 2
Risk

K922088 is an FDA 510(k) clearance for the FRESENIUS DIALYSATE ACID 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 October 17, 1994 after a review of 896 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

Submission Details

510(k) Number K922088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1992
Decision Date October 17, 1994
Days to Decision 896 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
766d slower than avg
Panel avg: 130d · This submission: 896d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 122
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K922088.
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Bicarby Dialysate RFP-402 (RFP-402-G)
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pureFLOW 402 (F00012067)
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