Cleared Traditional

K972206 - NIPRO BLOOD TUBING SET WITH TRANSDUCER ...

K972206 is the FDA 510(k) clearance for NIPRO BLOOD TUBING SET WITH TRANSDUCER ... by Nipro Medical Corp.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K972206 · Nipro Medical Corp. · Gastroenterology & Urology device
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Nov 1997
Decision
168d
Days
Class 2
Risk

K972206 is an FDA 510(k) clearance for the NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Nipro Medical Corp. (Lexington, US). The FDA issued a Cleared decision on November 26, 1997 after a review of 168 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 Nipro Medical Corp. devices

Submission Details

510(k) Number K972206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1997
Decision Date November 26, 1997
Days to Decision 168 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
38d slower than avg
Panel avg: 130d · This submission: 168d
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 122
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K972206.
CRIT-LINE CLIP (CLIC)
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K010268 · Fresenius Medical Care North America · Apr 2001
ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS
K955277 · Baxter Healthcare Corp · Feb 1996
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