Cleared Special

K002085 - ULTRASOUND SCANNER, TYPE 1101

K002085 is an FDA 510(k) clearance for ULTRASOUND SCANNER, manufactured by B & K Medical A/S. The device is a Class 2 Radiology device with product code IYO cleared through the Special 510(k) pathway after a 22-day FDA review.

K002085 · B & K Medical A/S · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
22d
Days
Class 2
Risk

K002085 is an FDA 510(k) clearance for the ULTRASOUND SCANNER, TYPE 1101. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by B & K Medical A/S (Dk 2820 Gentofte, DK). The FDA issued a Cleared decision on August 1, 2000 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K002085

510(k) Number K002085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2000
Decision Date August 01, 2000
Days to Decision 22 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 107d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 828
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K002085.
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K002085 · ULTRASOUND SCANNER, TYPE 1101
Download PDF FDA Summary B & K Medical A/S