Hampton, NH, US · 8 510(k) clearances · 7 recalls (7 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | Class II | Anesthesiology | 6 | 2026-01-15 |
| CBK | — | — | — | 2 | 2024-08-28 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-03-01 | Class I | Ongoing | Z-1357-2024 | Phantom 2 Nasal Vented Mask | — | Update to contraindications and warning language due to CPAP masks containing magnets. |
| 2024-03-01 | Class I | Ongoing | Z-1356-2024 | iQ 2 Nasal Vented Mask | — | Update to contraindications and warning language due to CPAP masks containing magnets. |
| 2024-03-01 | Class I | Ongoing | Z-1355-2024 | Mojo 2 Full Face AAV Non Vented Mask, All Sizes | — | Update to contraindications and warning language due to CPAP masks containing magnets. |
| 2024-03-01 | Class I | Ongoing | Z-1354-2024 | Mojo 2 Full Face Non Vented Mask, All Sizes | — | Update to contraindications and warning language due to CPAP masks containing magnets. |
| 2024-03-01 | Class I | Ongoing | Z-1353-2024 | Mojo 2 Full Face Vented Mask, All Sizes | — | Update to contraindications and warning language due to CPAP masks containing magnets. |
| 2024-03-01 | Class I | Ongoing | Z-1352-2024 | Mojo Non Vented Full Face Mask with Headgear, All Sizes | — | Update to contraindications and warning language due to CPAP masks containing magnets. |
| 2024-03-01 | Class I | Ongoing | Z-1351-2024 | Mojo Full Face with Headgear, All Sizes | — | Update to contraindications and warning language due to CPAP masks containing magnets. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-01-15 | K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | BZD | Class II | Anesthesiology |
| 2024-10-18 | K241830 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask | BZD | Class II | Anesthesiology |
| 2024-08-28 | K241943 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask | CBK | — | — |
| 2024-07-10 | K241661 | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask | BZD | Class II | Anesthesiology |
| 2024-06-27 | K241520 | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask | CBK | — | — |
| 2024-06-15 | K241469 | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | BZD | Class II | Anesthesiology |
| 2022-01-10 | K211274 | iQ 2 Nasal Mask, Phantom 2 Nasal Mask | BZD | Class II | Anesthesiology |
| 2021-04-30 | K203601 | Innova Nasal Non-Vented Mask | BZD | Class II | Anesthesiology |