510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SleepNet Corporation

Hampton, NH, US

SLEEPNET CORPORATION appears in FDA device records in Hampton, NH. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
23
PMA records
0
Recall records
7
Registered establishments
1

510(k) clearance history

FDA records hold 23 510(k) clearances for SleepNet Corporation between 1996 and 2026. The busiest year on record is 2024, with 5. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for SleepNet Corporation, by decision year
YearClearances
19963
19991
20011
20021
20061
20071
20091
20111
20123
20192
20211
20221
20245
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskBZDSubstantially Equivalent
K241830Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented MaskBZDSubstantially Equivalent
K241943Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented MaskCBKSubstantially Equivalent
K241661Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented MaskBZDSubstantially Equivalent
K241520Mojo 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 MaskCBKSubstantially Equivalent
K241469iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented MaskBZDSubstantially Equivalent
K211274iQ 2 Nasal Mask, Phantom 2 Nasal MaskBZDSubstantially Equivalent
K203601Innova Nasal Non-Vented MaskBZDSubstantially Equivalent
K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-VentedCBKSubstantially Equivalent
K190254Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskBZDSubstantially Equivalent
K121321HARD SHELL VENTED NASAL MASKBZDSubstantially Equivalent
K121692MINIME 2 NASAL MASKBZDSubstantially Equivalent
K120463MOJO, VERASEALBZDSubstantially Equivalent
K102317IQ VENTILATION NASAL MASKBZDSubstantially Equivalent
K090935MINIME PEDIATRIC MASKBZDSubstantially Equivalent
K063806SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTEDCBKSubstantially Equivalent
K060273SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837BZDSubstantially Equivalent
K021534IQ NASAL MASK, MODEL 50160 REV. DBZDSubstantially Equivalent
K013306MINIME NASAL MASK, MODEL P/N 50220BZDSubstantially Equivalent
K993269IQ NASAL MASK, MODEL P/N 50160BZDSubstantially Equivalent
K963025SLEEPNET HUMIDIFIER,(84200 PACKAGED)BTTSubstantially Equivalent
K962713DPAP STEALTH SLEEPNET MODEL NUMBER 84000BZDSubstantially Equivalent
K953697THE IMS DPAP MASK, IMS MODEL NUMBER 82000BZDSubstantially Equivalent

Registered establishments

FDA registered establishments for SleepNet Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
12220881222088SLEEPNET CORPORATION5 MERRILL INDUSTRIAL DRIVE, Hampton, NH 03842 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1357-2024Phantom 2 Nasal Vented MaskUpdate to contraindications and warning language due to CPAP masks containing magnets.Class IOpen, Classified
Z-1356-2024iQ 2 Nasal Vented MaskUpdate to contraindications and warning language due to CPAP masks containing magnets.Class IOpen, Classified
Z-1355-2024Mojo 2 Full Face AAV Non Vented Mask, All SizesUpdate to contraindications and warning language due to CPAP masks containing magnets.Class IOpen, Classified
Z-1354-2024Mojo 2 Full Face Non Vented Mask, All SizesUpdate to contraindications and warning language due to CPAP masks containing magnets.Class IOpen, Classified
Z-1353-2024Mojo 2 Full Face Vented Mask, All SizesUpdate to contraindications and warning language due to CPAP masks containing magnets.Class IOpen, Classified
Z-1352-2024Mojo Non Vented Full Face Mask with Headgear, All SizesUpdate to contraindications and warning language due to CPAP masks containing magnets.Class IOpen, Classified
Z-1351-2024Mojo Full Face with Headgear, All SizesUpdate to contraindications and warning language due to CPAP masks containing magnets.Class IOpen, Classified

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Data as of , FDA export datePage updated Source: openFDA, public domain