Cleared Traditional

K102194 - SOLCART B

K102194 is an FDA 510(k) clearance for SOLCART B, manufactured by B. Braun Avitum AG. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K102194 · B. Braun Avitum AG · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
264d
Days
Class 2
Risk

K102194 is an FDA 510(k) clearance for the SOLCART B. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by B. Braun Avitum AG (Allentown, US). The FDA issued a Cleared decision on April 25, 2011 after a review of 264 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 B. Braun Avitum AG devices

FDA 510(k) Submission Details - K102194

510(k) Number K102194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2010
Decision Date April 25, 2011
Days to Decision 264 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
134d slower than avg
Panel avg: 130d · This submission: 264d
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 52
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K102194.
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