510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231532Substantially Equivalent

ActiGraph LEAP activity monitor (ActiGraph LEAP)

ActiGraph L.L.C., Pensacola FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231532 is the FDA 510(k) clearance record for ActiGraph LEAP activity monitor (ActiGraph LEAP), a class II device, cleared for Actigraph, LLC on under FDA product code LEL (Device, Sleep Assessment). FDA records list 3 510(k) clearances for Actigraph, LLC, from to . As of , FDA records show no recalls naming K231532.

Clearance record

Decision date
Received
(28 days to decision)
Product code
LEL Device, Sleep Assessment
Regulation
21 CFR 882.5050
Device class
Class II
Review panel
Neurology
Applicant
Actigraph, LLC 70 N. Baylen St., Suite 400, Pensacola FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LEL

Trailing 12 months
1 clearance under product code LEL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LEL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260