Cleared Traditional

K162048 - EZstim*III Peripheral Nerve Stimulator/...

K162048 is an FDA 510(k) clearance for EZstim*III Peripheral Nerve Stimulator/..., manufactured by Halyard Health - Irvine. The device is a Class 2 Anesthesiology device with product code KOI cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K162048 · Halyard Health - Irvine · Anesthesiology device
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Dec 2016
Decision
133d
Days
Class 2
Risk

K162048 is an FDA 510(k) clearance for the EZstim*III Peripheral Nerve Stimulator/Nerve Locator. Classified as Stimulator, Nerve, Peripheral, Electric (product code KOI), Class II - Special Controls.

Submitted by Halyard Health - Irvine (Irvine, US). The FDA issued a Cleared decision on December 5, 2016 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2775 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Halyard Health - Irvine devices

FDA 510(k) Submission Details - K162048

510(k) Number K162048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2016
Decision Date December 05, 2016
Days to Decision 133 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 140d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOI Device Classification - Class 2, Special Controls

Product Code KOI Stimulator, Nerve, Peripheral, Electric
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 - KOI Stimulator, Nerve, Peripheral, Electric

All 23
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