510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090398Substantially Equivalent

Provent Professional Sleep Apnea Therapy

Ventus Medical, Inc., Belmont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090398 is the FDA 510(k) clearance record for PROVENT PROFESSIONAL SLEEP APNEA THERAPY, a class II device, cleared for Ventus Medical, Inc. on under FDA product code OHP (Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea). FDA's definition for product code OHP reads: "Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea". FDA records list 5 510(k) clearances for Ventus Medical, Inc., from to . As of , FDA records show one recall naming K090398.

Clearance record

Decision date
Received
(45 days to decision)
Product code
OHP Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Applicant
Ventus Medical, Inc. 1301 Shoreway Rd., Belmont CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OHP

Trailing 12 months

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

FDA records show no clearances under product code OHP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OHP, 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