SleepNet Corporation
FDA Regulatory Profile
SleepNet Corporation appears in FDA public data with 7 recalls — including 7 Class I (most serious) —, 23 510(k) clearances, 7 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1353-2024, Class I) was initiated on March 1, 2024. Its most recent 510(k) clearance was granted on January 15, 2026.
Summary
- Total Recalls
- 7 (7 Class I)
- 510(k) Clearances
- 23
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1353-2024 | Class I | Mojo 2 Full Face Vented Mask, All Sizes | March 1, 2024 |
| Z-1355-2024 | Class I | Mojo 2 Full Face AAV Non Vented Mask, All Sizes | March 1, 2024 |
| Z-1356-2024 | Class I | iQ 2 Nasal Vented Mask | March 1, 2024 |
| Z-1354-2024 | Class I | Mojo 2 Full Face Non Vented Mask, All Sizes | March 1, 2024 |
| Z-1357-2024 | Class I | Phantom 2 Nasal Vented Mask | March 1, 2024 |
| Z-1351-2024 | Class I | Mojo Full Face with Headgear, All Sizes | March 1, 2024 |
| Z-1352-2024 | Class I | Mojo Non Vented Full Face Mask with Headgear, All Sizes | March 1, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | January 15, 2026 |
| K241830 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend F | October 18, 2024 |
| K241943 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-V | August 28, 2024 |
| K241661 | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask | July 10, 2024 |
| K241520 | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Ven | June 27, 2024 |
| K241469 | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | June 15, 2024 |
| K211274 | iQ 2 Nasal Mask, Phantom 2 Nasal Mask | January 10, 2022 |
| K203601 | Innova Nasal Non-Vented Mask | April 30, 2021 |
| K190533 | Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Ven | July 26, 2019 |
| K190254 | Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask | July 5, 2019 |
| K121321 | HARD SHELL VENTED NASAL MASK | November 30, 2012 |
| K121692 | MINIME 2 NASAL MASK | November 5, 2012 |
| K120463 | MOJO, VERASEAL | July 27, 2012 |
| K102317 | IQ VENTILATION NASAL MASK | May 17, 2011 |
| K090935 | MINIME PEDIATRIC MASK | July 1, 2009 |
| K063806 | SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED | May 17, 2007 |
| K060273 | SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837 | May 2, 2006 |
| K021534 | IQ NASAL MASK, MODEL 50160 REV. D | July 2, 2002 |
| K013306 | MINIME NASAL MASK, MODEL P/N 50220 | November 2, 2001 |
| K993269 | IQ NASAL MASK, MODEL P/N 50160 | October 27, 1999 |