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

Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

21 CFR 872.5570 / Dental
FDA source (opens on fda.gov)

OHP is the FDA product code for Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea, a class II device type, regulated under 21 CFR 872.5570. FDA's definition for this code reads: "Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
OHP
Device name
Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
FDA definition
Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
5
Ingested recalls
2

Clearances, product code OHP

By decision year
5 clearances under product code OHP with a decision year between 2008 and 2020, 2008 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OHP by decision year
YearClearances
20081
20091
20101
20181
20201

Applicants with the most clearances

Product code OHP
Applicants holding the most 510(k) clearances under product code OHP
ApplicantClearances
Ventus Medical, Inc.3
Bryggs Medical, LLC1
Innomed Healthscience, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code