Cleared Special

K231532 - ActiGraph LEAP activity monitor (ActiGr...

K231532 is an FDA 510(k) clearance for ActiGraph LEAP activity monitor (ActiGr..., manufactured by Actigraph, LLC. The device is a Class 2 Neurology device with product code LEL cleared through the Special 510(k) pathway after a 28-day FDA review.

K231532 · Actigraph, LLC · Neurology device
Download Printable Device Report (PDF)
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Jun 2023
Decision
28d
Days
Class 2
Risk

K231532 is an FDA 510(k) clearance for the ActiGraph LEAP activity monitor (ActiGraph LEAP). Classified as Device, Sleep Assessment (product code LEL), Class II - Special Controls.

Submitted by Actigraph, LLC (Pensacola, US). The FDA issued a Cleared decision on June 23, 2023 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Actigraph, LLC devices

FDA 510(k) Submission Details - K231532

510(k) Number K231532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2023
Decision Date June 23, 2023
Days to Decision 28 days
Submission Type Special
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
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

LEL Device Classification - Class 2, Special Controls

Product Code LEL Device, Sleep Assessment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 Peers - LEL Device, Sleep Assessment

All 9
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