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510(k) K102404

PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) by Ventus Medical, Inc. — Product Code OHP

K102404 is an FDA 510(k) premarket notification submitted by Ventus Medical, Inc. for the device "PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)". The FDA issued a decision of Substantially Equivalent on December 2, 2010. The device falls under product code OHP (Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea), a Class II device regulated under 21 CFR 872.5570. Ventus Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2010
Date Received
August 24, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.

Other clearances by Ventus Medical, Inc.

  • K120665 — INVENT SNORING DEVICE (June 12, 2012)
  • K090398 — PROVENT PROFESSIONAL SLEEP APNEA THERAPY (April 3, 2009)
  • K080983 — PROVENT NASAL CANNULA (August 7, 2008)
  • K071560 — PROVENT NASAL DILATOR, MODEL BR2 (February 8, 2008)

Other clearances for product code OHP

  • K191728 — ULTepap Expiratory Positive Airway Pressure (EPAP) Device (February 21, 2020)
  • K180619 — Bongo (August 16, 2018)
  • K090398 — PROVENT PROFESSIONAL SLEEP APNEA THERAPY (April 3, 2009)
  • K071560 — PROVENT NASAL DILATOR, MODEL BR2 (February 8, 2008)

FDA data resources