FDA product code OHP: Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
OHP is the FDA product code for expiratory resistance valve, intranasal, for obstructive sleep apnea. It is a Class II device, regulated under 21 CFR 872.5570 and reviewed by the Dental panel. FDA has cleared 5 510(k) submissions under OHP, from 3 different applicants. The average 510(k) review took 158 days (median 160). FDA has posted 2 recalls for OHP devices.
Definition
Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.
Classification
| Field | Value |
|---|---|
| Device name | Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea |
| Device class | Class II |
| Regulation | 21 CFR 872.5570 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OHP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 160 |
| 2020 | 1 | 239 |
Compare with all 510(k) review times · Search every OHP clearance
Top OHP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ventus Medical, Inc. | 3 | 2010-12-02 |
| Bryggs Medical, LLC | 1 | 2020-02-21 |
| Innomed Healthscience, Inc. | 1 | 2018-08-16 |
Most recent OHP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191728 | Bryggs Medical, LLC | ULTepap Expiratory Positive Airway Pressure (EPAP) Device | 2020-02-21 | 239 |
| K180619 | Innomed Healthscience, Inc. | Bongo | 2018-08-16 | 160 |
| K102404 | Ventus Medical, Inc. | PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) | 2010-12-02 | 100 |
| K090398 | Ventus Medical, Inc. | PROVENT PROFESSIONAL SLEEP APNEA THERAPY | 2009-04-03 | 45 |
| K071560 | Ventus Medical, Inc. | PROVENT NASAL DILATOR, MODEL BR2 | 2008-02-08 | 246 |
Recalls for OHP devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-04-13.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code OHP?
OHP is the FDA product code for expiratory resistance valve, intranasal, for obstructive sleep apnea. It is a Class II device, regulated under 21 CFR 872.5570 and reviewed by the Dental panel.
What device class is OHP?
Class II, regulation 21 CFR 872.5570. Typical premarket route: 510(k).
How long does a 510(k) take for product code OHP?
Across 5 cleared submissions the average was 158 days from receipt to decision (median 160).
Which companies have the most OHP clearances?
Ventus Medical, Inc. (3); Bryggs Medical, LLC (1); Innomed Healthscience, Inc. (1).
Have OHP devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2020-04-13.
Next steps
- Run an FDA pathway report with predicate devices for product code OHP
- Run a recall and safety report across every OHP manufacturer
- Watch product code OHP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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