Cleared Traditional

K943338 - BIOSENSOR BIDOP VASCULAR TEST SYSTEM

K943338 is an FDA 510(k) clearance for BIOSENSOR BIDOP VASCULAR TEST SYSTEM, manufactured by Biosensor Corp.. The device is a Class 2 Radiology device with product code JAF cleared through the Traditional 510(k) pathway after a 640-day FDA review.

K943338 · Biosensor Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
640d
Days
Class 2
Risk

K943338 is an FDA 510(k) clearance for the BIOSENSOR BIDOP VASCULAR TEST SYSTEM. Classified as Monitor, Ultrasonic, Nonfetal (product code JAF), Class II - Special Controls.

Submitted by Biosensor Corp. (Minneapolis, US). The FDA issued a Cleared decision on April 12, 1996 after a review of 640 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1540 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Biosensor Corp. devices

FDA 510(k) Submission Details - K943338

510(k) Number K943338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1994
Decision Date April 12, 1996
Days to Decision 640 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
533d slower than avg
Panel avg: 107d · This submission: 640d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAF Device Classification - Class 2, Special Controls

Product Code JAF Monitor, Ultrasonic, Nonfetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1540
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 Radiology devices follow this clearance model.

Regulatory Peers - JAF Monitor, Ultrasonic, Nonfetal

All 16
Devices cleared under the same product code (JAF) and FDA review panel - the closest regulatory comparables to K943338.
IMEX STETHODOP
K973336 · Imex Medical Systems, Inc. · Feb 1998
FLOSTAT VASCULAR REPORT GENERATOR (VRG)
K973857 · Biomedix, Inc. · Dec 1997
FLOSTAT VASCULAR LAB
K973644 · Biomedix, Inc. · Dec 1997
IMWXDOP IR
K944196 · Imex Medical Systems, Inc. · May 1995
R AND D BATTERIES
K935427 · R & D Batteries, Inc. · Oct 1994
IMEXDOP CT+
K942441 · Imex Medical Systems, Inc. · Aug 1994