Cleared Abbreviated

STUDIODOP VICORDER (K071730) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K071730 · Skidmore Medical, Limited · Cardiovascular device
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Dec 2007
Decision
178d
Days
Class 2
Risk

K071730 is an FDA 510(k) clearance for the STUDIODOP VICORDER. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Skidmore Medical, Limited (Evergreen, US). The FDA issued a Cleared decision on December 20, 2007 after a review of 178 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - the FDA cardiovascular device 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 Skidmore Medical, Limited devices

Submission Details

510(k) Number K071730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2007
Decision Date December 20, 2007
Days to Decision 178 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 125d · This submission: 178d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - JOP Transducer, Ultrasonic

All 71
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