SleepNet Corporation

FDA Regulatory Profile

Summary

Total Recalls
7 (7 Class I)
510(k) Clearances
23
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1356-2024Class IiQ 2 Nasal Vented MaskMarch 1, 2024
Z-1354-2024Class IMojo 2 Full Face Non Vented Mask, All SizesMarch 1, 2024
Z-1357-2024Class IPhantom 2 Nasal Vented MaskMarch 1, 2024
Z-1353-2024Class IMojo 2 Full Face Vented Mask, All SizesMarch 1, 2024
Z-1351-2024Class IMojo Full Face with Headgear, All SizesMarch 1, 2024
Z-1352-2024Class IMojo Non Vented Full Face Mask with Headgear, All SizesMarch 1, 2024
Z-1355-2024Class IMojo 2 Full Face AAV Non Vented Mask, All SizesMarch 1, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskJanuary 15, 2026
K241830Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend FOctober 18, 2024
K241943Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-VAugust 28, 2024
K241661Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskJuly 10, 2024
K241520Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-VenJune 27, 2024
K241469iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented MaskJune 15, 2024
K211274iQ 2 Nasal Mask, Phantom 2 Nasal MaskJanuary 10, 2022
K203601Innova Nasal Non-Vented MaskApril 30, 2021
K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-VenJuly 26, 2019
K190254Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskJuly 5, 2019
K121321HARD SHELL VENTED NASAL MASKNovember 30, 2012
K121692MINIME 2 NASAL MASKNovember 5, 2012
K120463MOJO, VERASEALJuly 27, 2012
K102317IQ VENTILATION NASAL MASKMay 17, 2011
K090935MINIME PEDIATRIC MASKJuly 1, 2009
K063806SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTEDMay 17, 2007
K060273SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837May 2, 2006
K021534IQ NASAL MASK, MODEL 50160 REV. DJuly 2, 2002
K013306MINIME NASAL MASK, MODEL P/N 50220November 2, 2001
K993269IQ NASAL MASK, MODEL P/N 50160October 27, 1999