Cleared Traditional

K220160 - PediGuard Threaded (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220160 · Spineguard S.A. · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 2022
Decision
71d
Days
Class 2
Risk

K220160 is an FDA 510(k) clearance for the PediGuard Threaded. Classified as Neurosurgical Nerve Locator (product code PDQ), Class II - Special Controls.

Submitted by Spineguard S.A. (Vincennes, FR). The FDA issued a Cleared decision on March 31, 2022 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 874.1820 - the FDA neurology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spineguard S.A. devices

Submission Details

510(k) Number K220160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2022
Decision Date March 31, 2022
Days to Decision 71 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 148d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDQ Neurosurgical Nerve Locator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
Definition To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.
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 Neurology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells Llp
John Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PDQ Neurosurgical Nerve Locator

All 34
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