Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list SleepNet Corporation with 23 510(k) clearances and 7 device recalls. The most recent is a 510(k) clearance dated Jan 15, 2026: Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jan 15, 2026 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskK251847 · BZD | 510(k) clearances |
| Oct 18, 2024 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented MaskK241830 · BZD | 510(k) clearances |
| Aug 28, 2024 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented MaskK241943 · CBK | 510(k) clearances |
| Jul 10, 2024 | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskK241661 · BZD | 510(k) clearances |
| Jun 27, 2024 | 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 MaskK241520 · CBK | 510(k) clearances |
| Jun 15, 2024 | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented MaskK241469 · BZD | 510(k) clearances |
| Mar 1, 2024 | Mojo 2 Full Face AAV Non Vented Mask, All SizesClass I · Update to contraindications and warning language due to CPAP masks containing magnets. | Device recalls |
| Mar 1, 2024 | iQ 2 Nasal Vented MaskClass I · Update to contraindications and warning language due to CPAP masks containing magnets. | Device recalls |
| Mar 1, 2024 | Mojo 2 Full Face Non Vented Mask, All SizesClass I · Update to contraindications and warning language due to CPAP masks containing magnets. | Device recalls |
| Mar 1, 2024 | Mojo Non Vented Full Face Mask with Headgear, All SizesClass I · Update to contraindications and warning language due to CPAP masks containing magnets. | Device recalls |
| Mar 1, 2024 | Mojo 2 Full Face Vented Mask, All SizesClass I · Update to contraindications and warning language due to CPAP masks containing magnets. | Device recalls |
| Mar 1, 2024 | Phantom 2 Nasal Vented MaskClass I · Update to contraindications and warning language due to CPAP masks containing magnets. | Device recalls |
| Mar 1, 2024 | Mojo Full Face with Headgear, All SizesClass I · Update to contraindications and warning language due to CPAP masks containing magnets. | Device recalls |
| Jan 10, 2022 | iQ 2 Nasal Mask, Phantom 2 Nasal MaskK211274 · BZD | 510(k) clearances |
| Apr 30, 2021 | Innova Nasal Non-Vented MaskK203601 · BZD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
