510(k) · Cleared

Cleared

Imask TM

K041309510(k) TraditionalCleared Jun 30, 200444-day reviewClass II21 CFR 868.5905

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vital Signs, Inc. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Jun 30, 2004 as substantially equivalent to K993269 (Sleepnet Corporation, 1999) after a 44-day review. Its family tree reaches back 1 generation to 1999.

Decided: Jun 30, 2004
Review: 44 days
Class: Class II
Product code: BZD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K993269 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK993269 IQ Nasal Mask, Model P/N 50160Sleepnet Corporation · 1999
This deviceK041309 Imask TMVital Signs, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K993269	IQ Nasal Mask, Model P/N 50160	Sleepnet Corporation	1999	—
0 (this device)	K041309	Imask TM	Vital Signs, Inc.	2004	—

FIG. 1 — Lineage of K041309, 1999–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new BZD device

#1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K993269	IQ Nasal Mask, Model P/N 50160 Summary page 1 …irator) Subsection 868.5905 Intended Device: CPAP Nasal Mask Predicate Device: SleepNet Corporation IQ TM Mask - K993269 Device Description: A nasal CPAP mask that is used with positive airway pressure equipme…	Sleepnet Corporation	1999	—

Also cleared against K993269: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
1 other device also cites its predicate K993269.

How does its category compare?

All BZD devices

BZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZD

7in 2025

2007high 23 (2009) · low 4 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZD

189in 2025

2007high 280 (2018) · low 83 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BZD

8in 2023

2007high 29 (2007) · low 0 (2010)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · BZD

60,279in 2025

2007high 90,768 (2022) · low 65 (2007)2025

MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	21	83	29	65
2008	17	108	2	67
2009	23	90	1	147
2010	12	122	0	143
2011	23	125	1	189
2012	21	133	0	139
2013	23	127	0	82
2014	14	172	0	86
2015	11	224	0	114
2016	12	217	0	118
2017	5	221	0	148
2018	5	280	0	101
2019	6	231	4 (4)	188
2020	6	137	0	126
2021	6	192	0	6,066
2022	4	253	0	90,768
2023	5	204	8 (7)	27,987
2024	10	132	0	68,262
2025	7	189	0	60,279
2026	10	214	2 (2)	—

What is it indicated for?

This device is intended to be used with positive airway pressure devices operating at or above 4cmH20 for the treatment of adult obstructive sleep apnea.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041309 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041309: Imask TM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041309

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026