Cleared Traditional

K920797 - HEMODIALYSIS BLOOD TUBING SET

K920797 is an FDA 510(k) clearance for HEMODIALYSIS BLOOD TUBING SET, manufactured by National Medical Care, Medical Products Div., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K920797 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
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Sep 1992
Decision
213d
Days
Class 2
Risk

K920797 is an FDA 510(k) clearance for the HEMODIALYSIS BLOOD TUBING SET. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by National Medical Care, Medical Products Div., Inc. (Rockleigh, US). The FDA issued a Cleared decision on September 21, 1992 after a review of 213 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.

FDA 510(k) Submission Details - K920797

510(k) Number K920797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1992
Decision Date September 21, 1992
Days to Decision 213 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 131d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJK Device Classification - Class 2, Special Controls

Product Code FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve
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 - FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve

All 76
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K920797.
TS 564/PF
K950247 · Bressler, Amery & Ross · Nov 1995
CAVH/CVVH/CAVHD SET MODEL #HT-HF/505
K921597 · Haemotronic, Inc. · Feb 1995
ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS
K934803 · Baxter Healthcare Corp · Dec 1993
SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS
K913526 · Althin Medical AB an Affiliate of Baxter Intl · Nov 1991
TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET
K910558 · Terumo Medical Corp. · Aug 1991
HEMODIALYSIS SYSTEM AND ACCESSORY
K902426 · Gainor Medical Europe, Ltd. · Nov 1990
K920797 · HEMODIALYSIS BLOOD TUBING SET
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