Cleared Traditional

K892932 - BIOPRIME TM KIT

K892932 is an FDA 510(k) clearance for BIOPRIME TM KIT, manufactured by Hospal. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K892932 · Hospal · Gastroenterology & Urology device
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Jun 1989
Decision
62d
Days
Class 2
Risk

K892932 is an FDA 510(k) clearance for the BIOPRIME TM KIT. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Hospal (Williamsburg, US). The FDA issued a Cleared decision on June 22, 1989 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hospal devices

FDA 510(k) Submission Details - K892932

510(k) Number K892932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1989
Decision Date June 22, 1989
Days to Decision 62 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
68d faster than avg
Panel avg: 130d · This submission: 62d
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 K892932.
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