Cleared Traditional

K910558 - TERUMO ARTERIAL AND VENOUS BLOOD LINE SET

K910558 is an FDA 510(k) clearance for TERUMO ARTERIAL AND VENOUS BLOOD LINE SET, manufactured by Terumo Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K910558 · Terumo Medical Corp. · Gastroenterology & Urology device
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Aug 1991
Decision
180d
Days
Class 2
Risk

K910558 is an FDA 510(k) clearance for the TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on August 7, 1991 after a review of 180 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K910558

510(k) Number K910558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1991
Decision Date August 07, 1991
Days to Decision 180 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
50d slower than avg
Panel avg: 130d · This submission: 180d
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 46
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K910558.
ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS
K934803 · Baxter Healthcare Corp · Dec 1993
HEMODIALYSIS BLOOD TUBING SET
K920797 · National Medical Care, Medical Products Div., Inc. · Sep 1992
SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS
K913526 · Althin Medical AB an Affiliate of Baxter Intl · Nov 1991
NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630
K903021 · National Medical Care, Medical Products Div., Inc. · Aug 1990
ARTERIAL/VENOUS BLOODLINES
K901688 · National Medical Care, Medical Products Div., Inc. · Aug 1990
LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE
K870722 · National Medical Care, Medical Products Div., Inc. · Sep 1988