Company ยท US
Sleepnet Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2026. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (1 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 15, 2026 | K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask Sleepnet Corporation | BZD |
| Oct 18, 2024 | K241830 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask Sleepnet Corporation | BZD |
| Aug 28, 2024 | K241943 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask Sleepnet Corporation | CBK |
| Jul 10, 2024 | K241661 | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask Sleepnet Corporation | BZD |
| Jun 27, 2024 | 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 Sleepnet Corporation | CBK |
| Jun 15, 2024 | K241469 | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask Sleepnet Corporation | BZD |
| Jan 10, 2022 | K211274 | iQ 2 Nasal Mask, Phantom 2 Nasal Mask Sleepnet Corporation | BZD |
| Apr 30, 2021 | K203601 | Innova Nasal Non-Vented Mask Sleepnet Corporation | BZD |
| Jul 26, 2019 | K190533 | Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Sleepnet Corporation | CBK |
| Jul 5, 2019 | K190254 | Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask Sleepnet Corporation | BZD |
| Nov 30, 2012 | K121321 | HARD SHELL VENTED NASAL MASK Sleepnet Corporation | BZD |
| Nov 5, 2012 | K121692 | MINIME 2 NASAL MASK Sleepnet Corporation | BZD |
| Jul 27, 2012 | K120463 | MOJO, VERASEAL Sleepnet Corporation | BZD |
| May 17, 2011 | K102317 | IQ VENTILATION NASAL MASK Sleepnet Corporation | BZD |
| Jul 1, 2009 | K090935 | MINIME PEDIATRIC MASK Sleepnet Corporation | BZD |
| May 17, 2007 | K063806 | SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED Sleepnet Corporation | CBK |
| May 2, 2006 | K060273 | SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837 Sleepnet Corporation | BZD |
| Jul 2, 2002 | K021534 | IQ NASAL MASK, MODEL 50160 REV. D Sleepnet Corporation | BZD |
| Nov 2, 2001 | K013306 | MINIME NASAL MASK, MODEL P/N 50220 Sleepnet Corporation | BZD |
| Oct 27, 1999 | K993269 | IQ NASAL MASK, MODEL P/N 50160 Sleepnet Corporation | BZD |
| Nov 1, 1996 | K963025 | SLEEPNET HUMIDIFIER,(84200 PACKAGED) Sleepnet Corporation | BTT |
| Oct 23, 1996 | K962713 | DPAP STEALTH SLEEPNET MODEL NUMBER 84000 Sleepnet Corporation | BZD |
| Jun 13, 1996 | K953697 | THE IMS DPAP MASK, IMS MODEL NUMBER 82000 Sleepnet Corporation | BZD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2024 | SleepNet Corporation Phantom 2 Nasal Vented Mask Open, Classified |
BZD | K211274 |
| Apr 1, 2024 | SleepNet Corporation iQ 2 Nasal Vented Mask Open, Classified |
BZD | K211274 |
| Apr 1, 2024 | SleepNet Corporation Mojo 2 Full Face AAV Non Vented Mask, All Sizes Open, Classified |
BZD | K190533 |
| Apr 1, 2024 | SleepNet Corporation Mojo 2 Full Face Non Vented Mask, All Sizes Open, Classified |
BZD | K190533 |
| Apr 1, 2024 | SleepNet Corporation Mojo 2 Full Face Vented Mask, All Sizes Open, Classified |
BZD | K190254 |
| Apr 1, 2024 | SleepNet Corporation Mojo Non Vented Full Face Mask with Headgear, All Sizes Open, Classified |
BZD | K063806 |
| Apr 1, 2024 | SleepNet Corporation Mojo Full Face with Headgear, All Sizes Open, Classified |
BZD | K120463 |