510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K965079Substantially Equivalent

Somnitor 32K Sleep Activity Monitor

Neurim Pharmaceuticals, Ltd., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965079 is the FDA 510(k) clearance record for SOMNITOR 32K SLEEP ACTIVITY MONITOR, a class II device, cleared for Neurim Pharmaceuticals, Ltd. on under FDA product code LEL (Device, Sleep Assessment). FDA records list one 510(k) clearance for Neurim Pharmaceuticals, Ltd. As of , FDA records show no recalls naming K965079.

Clearance record

Decision date
Received
(203 days to decision)
Product code
LEL Device, Sleep Assessment
Regulation
21 CFR 882.5050
Device class
Class II
Review panel
Neurology
Applicant
Neurim Pharmaceuticals, Ltd. 12300 Twinbrook Pkwy., Suit5, Rockville MD
510(k) summary
Summary
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