Cleared Traditional

bibag (K162716) - FDA 510(k) Clearance

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

K162716 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device
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May 2017
Decision
231d
Days
Class 2
Risk

K162716 is an FDA 510(k) clearance for the bibag. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on May 18, 2017 after a review of 231 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 Fresenius Medical Care Renal Therapies Group, LLC devices

Submission Details

510(k) Number K162716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2016
Decision Date May 18, 2017
Days to Decision 231 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
101d slower than avg
Panel avg: 130d · This submission: 231d
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 30
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K162716.
Isopure Dry Acid Dissolution System
K191093 · Isopure, Corp. · Jan 2020
CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)
K180679 · Global Scientific Technologies, LLC · Dec 2018
Citric Complete Dry Citric Acid (45X)
K171750 · Dimesol USA, LLC · Mar 2018
ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A
K090002 · Baxter Healthcare Corp · Aug 2009
B. BRAUN MODIFIED BICARBONATE DIALYSATE
K052393 · B.Braun Medical, Inc. · Nov 2005
ACCUSOL DIALYSIS SOLUTION
K041428 · Baxter Healthcare Corp · Aug 2004