Cleared Abbreviated

K062478 - CLAVIS

K062478 is an FDA 510(k) clearance for CLAVIS, manufactured by Medtronic A/S. The device is a Class 2 Anesthesiology device with product code BXN cleared through the Abbreviated 510(k) pathway after a 168-day FDA review.

K062478 · Medtronic A/S · Anesthesiology device
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Feb 2007
Decision
168d
Days
Class 2
Risk

K062478 is an FDA 510(k) clearance for the CLAVIS. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Medtronic A/S (Skovlunde, DK). The FDA issued a Cleared decision on February 8, 2007 after a review of 168 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2775 - the FDA anesthesiology and respiratory device 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 Medtronic A/S devices

FDA 510(k) Submission Details - K062478

510(k) Number K062478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2006
Decision Date February 08, 2007
Days to Decision 168 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 140d · This submission: 168d
Pathway characteristics
Standards-based clearance path.

BXN Device Classification - Class 2, Special Controls

Product Code BXN Stimulator, Nerve, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2775
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BXN Stimulator, Nerve, Battery-powered

All 29
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K062478.
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