Cleared Traditional

K896407 - HAEMOTRONIC BLOOD LINE SET

K896407 is an FDA 510(k) clearance for HAEMOTRONIC BLOOD LINE SET, manufactured by Healthcare Suppliers, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K896407 · Healthcare Suppliers, Inc. · Gastroenterology & Urology device
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Apr 1990
Decision
169d
Days
Class 2
Risk

K896407 is an FDA 510(k) clearance for the HAEMOTRONIC BLOOD LINE SET. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Healthcare Suppliers, Inc. (Jackson, US). The FDA issued a Cleared decision on April 25, 1990 after a review of 169 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 Healthcare Suppliers, Inc. devices

FDA 510(k) Submission Details - K896407

510(k) Number K896407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1989
Decision Date April 25, 1990
Days to Decision 169 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 130d · This submission: 169d
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 45
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K896407.
TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET
K910558 · Terumo Medical Corp. · Aug 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
ERIKA ARTERIAL LINE 03-9625-9
K860740 · National Medical Care, Medical Products Div., Inc. · Mar 1986
ASA BLOOD TUBING LINES
K854271 · Organon Teknika Corp. · Nov 1985