510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261011Substantially Equivalent

Sleep Apnea Feature (v2.0)

Samsung Electronics Co., Ltd., Suwon-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K261011 is the FDA 510(k) clearance record for Sleep Apnea Feature (v2.0), a class II device, cleared for Samsung Electronics Co., Ltd. on under FDA product code QZW (Over-The-Counter Device To Assess Risk Of Sleep Apnea). FDA's definition for product code QZW reads: "An over-the-counter device to assess risk of sleep apnea is intended to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed with sleep apnea. This device uses software algorithms to analyze...". FDA records list 42 510(k) clearances for Samsung Electronics Co., Ltd., from to . As of , FDA records show no recalls naming K261011.

Clearance record

Decision date
Received
(116 days to decision)
Product code
QZW Over-The-Counter Device To Assess Risk Of Sleep Apnea
Regulation
21 CFR 868.2378
Device class
Class II
Review panel
Anesthesiology
Applicant
Samsung Electronics Co., Ltd. 129 Samsung-Ro, Yeoungton-Gu, Suwon-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QZW

Trailing 12 months
1 clearance under product code QZW in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QZW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260