Data / Medical devices / United States / Sleepnet Corporation

Sleepnet Corporation: FDA-registered device maker in Hampton, NH, United States, 11 510(k) clearances

Name: Sleepnet Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sleepnet Corporation is registered with the FDA (registration 1222088) in Hampton, NH, United States. It lists 2 device types. The FDA files 11 510(k) clearances under its listings, the newest dated January 15, 2026. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1222088
Address: 5 Merrill Industrial Drive, Hampton, NH, United States, 03842
Owner or operator: SLEEPNET CORPORATION (9024494)
Roles: Manufacturer, Manufacturer for export
First device listed: November 20, 2007
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Ventilator, Continuous, Facility Use	CBK	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Ventilator, Non-Continuous (Respirator)	BZD	2	Manufacturer, Manufacturer for export	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 15, 2026	K251847	Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask	BZD	Substantially Equivalent	Sleepnet Corporation	accessdata.fda.gov
October 18, 2024	K241830	Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask	BZD	Substantially Equivalent	Sleepnet Corporation	accessdata.fda.gov
August 28, 2024	K241943	Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask	CBK	Substantially Equivalent	Sleepnet Corporation	accessdata.fda.gov
July 10, 2024	K241661	Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask	BZD	Substantially Equivalent	Sleepnet Corporation	accessdata.fda.gov
June 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 Full Face AAV Non-Vented Mask	CBK	Substantially Equivalent	Sleepnet Corporation	accessdata.fda.gov
June 15, 2024	K241469	iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask	BZD	Substantially Equivalent	Sleepnet Corporation	accessdata.fda.gov
April 30, 2021	K203601	Innova Nasal Non-Vented Mask	BZD	Substantially Equivalent	Sleepnet Corporation	accessdata.fda.gov
November 30, 2012	K121321	HARD SHELL VENTED NASAL MASK	BZD	Substantially Equivalent	Sleepnet Corporation	accessdata.fda.gov
November 5, 2012	K121692	MINIME 2 NASAL MASK	BZD	Substantially Equivalent	Sleepnet Corporation	accessdata.fda.gov
July 1, 2009	K090935	MINIME PEDIATRIC MASK	BZD	Substantially Equivalent	Sleepnet Corporation	accessdata.fda.gov
July 2, 2002	K021534	IQ NASAL MASK, MODEL 50160 REV. D	BZD	Substantially Equivalent	Sleepnet Corporation	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 1, 2024	94169	Class I	Ongoing	Mojo Full Face with Headgear, All Sizes	Update to contraindications and warning language due to CPAP masks containing magnets.	accessdata.fda.gov

Compare with other makers

Updated January 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.