Ventus Medical, Inc.
Hillsborough, CA, US
Ventus Medical, Inc. appears in FDA device records in Hillsborough, CA. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Ventus Medical, Inc. between 2008 and 2012. The busiest year on record is 2008, with 2. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K120665 | INVENT SNORING DEVICE | LWF | Substantially Equivalent | |
| K102404 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) | OHP | Substantially Equivalent | |
| K090398 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY | OHP | Substantially Equivalent | |
| K080983 | PROVENT NASAL CANNULA | MNR | Substantially Equivalent | |
| K071560 | PROVENT NASAL DILATOR, MODEL BR2 | OHP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1033-2012 | Provent -SR - Sleep Apnea Therapy-SR (standard resistance). Prescription only, Single Use; Packed 30 units per box Manufactured in the USA by Ventus Medical Inc. 1301 Shoreway Road, Suite 425; Belmont, CA 94002 Used in the treatment of obstructive sleep apnea. | A discrepancy was found during inspection of a returned unit that the lot number and SKU on cartoon did not match. | Terminated | ||
| Z-2435-2010 | The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to be used for transmission of respiratory airflow signals between the Provent Professional Sleep Apnea Therapy device and physiologic recorders. | The catalog number printed on two Nasal Cannula Diagnostic Kits (MRS0231) was different that the catalog number printed on the bulk pack shipper box and the other Nasal Cannula Kits in the same shipper (MRS0208). No devices were used on any patient . | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain