Cleared Abbreviated

K030466 - HANDYDOP

K030466 is an FDA 510(k) clearance for HANDYDOP, manufactured by Elcat, GmbH. The device is a Class 2 Radiology device with product code KNG cleared through the Abbreviated 510(k) pathway after a 212-day FDA review.

K030466 · Elcat, GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
212d
Days
Class 2
Risk

K030466 is an FDA 510(k) clearance for the HANDYDOP. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Elcat, GmbH (Alpharetta, US). The FDA issued a Cleared decision on September 12, 2003 after a review of 212 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2660 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Elcat, GmbH devices

FDA 510(k) Submission Details - K030466

510(k) Number K030466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2003
Decision Date September 12, 2003
Days to Decision 212 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 107d · This submission: 212d
Pathway characteristics
Standards-based clearance path.

KNG Device Classification - Class 2, Special Controls

Product Code KNG Monitor, Ultrasonic, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
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 - KNG Monitor, Ultrasonic, Fetal

All 37
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K030466.
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