510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861758Substantially Equivalent

Cushion-Flex Tm Nasal CPAP Mask for Sleep Apnea

Life Design Systems, Inc., Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861758 is the FDA 510(k) clearance record for CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA, a class II device, cleared for Life Design Systems, Inc. on under FDA product code BYE (Attachment, Breathing, Positive End Expiratory Pressure). FDA records list 29 510(k) clearances for Life Design Systems, Inc., from to . As of , FDA records show no recalls naming K861758.

Clearance record

Decision date
Received
(69 days to decision)
Product code
BYE Attachment, Breathing, Positive End Expiratory Pressure
Regulation
21 CFR 868.5965
Device class
Class II
Review panel
Anesthesiology
Applicant
Life Design Systems, Inc. 11017 W. Layton Ave., Milwaukee WI
Third party review
No

Clearances, product code BYE

Trailing 12 months

FDA records hold no clearances under product code BYE in the trailing twelve months.

FDA records show no clearances under product code BYE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BYE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260