Cleared Traditional

K952572 - DIALYSIS ADMINISTRATION KITS

K952572 is the FDA 510(k) clearance for DIALYSIS ADMINISTRATION KITS by B.Braun Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K952572 · B.Braun Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
220d
Days
Class 2
Risk

K952572 is an FDA 510(k) clearance for the DIALYSIS ADMINISTRATION KITS. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on January 11, 1996 after a review of 220 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 Medical, Inc. devices

Submission Details

510(k) Number K952572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1995
Decision Date January 11, 1996
Days to Decision 220 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 130d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOC Accessories, Blood Circuit, Hemodialysis
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 114
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K952572.
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K955277 · Baxter Healthcare Corp · Feb 1996
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K950282 · KARL STORZ Endoscopy-America, Inc. · Apr 1995
SILICONE CATHETER REPAIR KITS
K926374 · Akcess Medical Products, Inc. · Oct 1994
BARD UROTRACK II MONITORING
K924436 · C.R. Bard, Inc. · Mar 1994