Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sleepnet Corporation — Predicate Candidate Screening

23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

116 daysmedian FDA review time

258 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K251847	Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Ven	Sleepnet Corporation	2026-01-15	213	0
K241830	Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask	Sleepnet Corporation	2024-10-18	116	0
K241943	Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Ven	Sleepnet Corporation	2024-08-28	57	0
K241661	Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Ma	Sleepnet Corporation	2024-07-10	30	0
K241520	Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-V	Sleepnet Corporation	2024-06-27	29	0
K241469	iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask	Sleepnet Corporation	2024-06-15	22	0
K211274	iQ 2 Nasal Mask, Phantom 2 Nasal Mask	Sleepnet Corporation	2022-01-10	258	2
K203601	Innova Nasal Non-Vented Mask	Sleepnet Corporation	2021-04-30	142	0
K190533	Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full	Sleepnet Corporation	2019-07-26	144	2
K190254	Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Ma	Sleepnet Corporation	2019-07-05	148	1
K121321	HARD SHELL VENTED NASAL MASK	Sleepnet Corporation	2012-11-30	212	0
K121692	MINIME 2 NASAL MASK	Sleepnet Corporation	2012-11-05	151	0
K120463	MOJO, VERASEAL	Sleepnet Corporation	2012-07-27	163	1
K102317	IQ VENTILATION NASAL MASK	Sleepnet Corporation	2011-05-17	274	0
K090935	MINIME PEDIATRIC MASK	Sleepnet Corporation	2009-07-01	90	0
K063806	SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED	Sleepnet Corporation	2007-05-17	146	1
K060273	SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM	Sleepnet Corporation	2006-05-02	89	0
K021534	IQ NASAL MASK, MODEL 50160 REV. D	Sleepnet Corporation	2002-07-02	53	0
K013306	MINIME NASAL MASK, MODEL P/N 50220	Sleepnet Corporation	2001-11-02	29	0
K993269	IQ NASAL MASK, MODEL P/N 50160	Sleepnet Corporation	1999-10-27	27	0
K963025	SLEEPNET HUMIDIFIER,(84200 PACKAGED)	Sleepnet Corporation	1996-11-01	88	0
K962713	DPAP STEALTH SLEEPNET MODEL NUMBER 84000	Sleepnet Corporation	1996-10-23	103	0
K953697	THE IMS DPAP MASK, IMS MODEL NUMBER 82000	Sleepnet Corporation	1996-06-13	310	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda