Cleared Traditional

K901688 - ARTERIAL/VENOUS BLOODLINES

K901688 is an FDA 510(k) clearance for ARTERIAL/VENOUS BLOODLINES, 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 112-day FDA review.

K901688 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
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Aug 1990
Decision
112d
Days
Class 2
Risk

K901688 is an FDA 510(k) clearance for the ARTERIAL/VENOUS BLOODLINES. 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 August 2, 1990 after a review of 112 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.

FDA 510(k) Submission Details - K901688

510(k) Number K901688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1990
Decision Date August 02, 1990
Days to Decision 112 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 131d · This submission: 112d
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 K901688.
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
NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630
K903021 · National Medical Care, Medical Products Div., Inc. · Aug 1990
HAEMOTRONIC BLOOD LINE SET
K896407 · Healthcare Suppliers, Inc. · Apr 1990
BIOPRIME TM KIT
K892932 · Hospal · Jun 1989
BLOOD TUBING SET
K884243 · Mediflex Intl. · Dec 1988
K901688 · ARTERIAL/VENOUS BLOODLINES
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