Cleared Traditional

K955277 - ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS

K955277 is an FDA 510(k) clearance for ARTERIAL BLOOD TUBING SET FOR SINGLE NE..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K955277 · Baxter Healthcare Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
91d
Days
Class 2
Risk

K955277 is an FDA 510(k) clearance for the ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on February 16, 1996 after a review of 91 days - within the typical 510(k) review window.

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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K955277

510(k) Number K955277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1995
Decision Date February 16, 1996
Days to Decision 91 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
40d faster than avg
Panel avg: 131d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOC Device Classification - Class 2, Special Controls

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 141
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K955277.
MEDISYSTEMS DIALYSIS PRIMING SETS
K971860 · Medisystems Corp. · Aug 1997
NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS
K954676 · Nissho Corp. · Mar 1997
CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS
K964041 · Robert R. Stevens · Jan 1997
DIALYSIS ADMINISTRATION KITS
K952572 · B.Braun Medical, Inc. · Jan 1996
KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA
K950282 · KARL STORZ Endoscopy-America, Inc. · Apr 1995
DIAL MEDICAL KIT
K941543 · Regulatory & Marketing Services, Inc. · Feb 1995