510(k) · Cleared

Cleared

Advantage Nasal Mask, Small, Advantage Nasal Mask. Regular, Models TMS-2520, TMS 2530

K012207510(k) SpecialCleared Jul 23, 20017-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

Tiara Medical Systems, Inc. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Jul 23, 2001 after a 7-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 of the 27 devices in its family, counting itself, have a Class I recall. 26 later devices descend from it.

Decided: Jul 23, 2001
Review: 7 days
Class: Class II
Product code: BZD
Recalls: None
Predicates: 0

26 later devices descend from it, 3 citing it directly. 8 of the 27 devices in this family, counting this one, have a Class I recall.

This deviceK012207 Advantage Nasal Mask, Small, Advantage Nasal Mask. Regular, Models…Tiara Medical Systems, Inc. · 2001
Descendant · cites it directly · 23 of its ownK031935 Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and…Tiara Medical Systems, Inc. · 2004
Descendant · 2 generations on · 21 of its ownK043382 TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc. · 2005
Descendant · 3 generations on · 20 of its ownK060273 Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model…Sleepnet Corporation · 2006
Descendant · 4 generations on · 7 of its ownK132887 Airfit N10Resmed, Ltd. · 2013 · Recalled (Class I)
Descendant · 5 generations on · 6 of its ownK153673 AirFit N20Resmed, Ltd. · 2016

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2004high 3 (2024) · low 0 (2009)2026

Class I recalls in this family

K132887 Airfit N104 generations on · 2013
K063806 Sleepnet Mojo -NV Full Face Mask, Non-Vented4 generations on · 2007
K081743 Classicstar NV SE and Novastar NV SE and Aav…4 generations on · 2008
K120463 Mojo, Veraseal4 generations on · 2012

Most influential descendants

Showing 5 of 26 · See all

K031935Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and TMS-2530Tiara Medical Systems, Inc. · 2004 · cites it directly23descendants
K043382TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc. · 2005 · 2 generations on21descendants
K060273Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model…Sleepnet Corporation · 2006 · 3 generations on20descendants
K132887Airfit N10Resmed, Ltd. · 2013 · 4 generations on7descendants
K153673AirFit N20Resmed, Ltd. · 2016 · 5 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K012207	Advantage Nasal Mask, Small, Advantage Nasal Mask. Regular, Models TMS-2520…	Tiara Medical Systems, Inc.	2001	—
+1	K031935	Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and TMS-2530	Tiara Medical Systems, Inc.	2004	—
+2	K043382	TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840	Tiara Medical Systems, Inc.	2005	—
+3	K060273	Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model…	Sleepnet Corporation	2006	—
+4	K132887	Airfit N10	Resmed, Ltd.	2013	Class I
+5	K153673	AirFit N20	Resmed, Ltd.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	2	0
2006	1	0
2007	1	1
2008	1	1
2010	1	0
2011	1	0
2012	2	1
2013	1	1
2016	2	1
2017	1	1
2018	1	0
2019	2	2
2021	2	0
2023	1	0
2024	3	0
2026	2	0

FIG. 1 — Lineage of K012207, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

8 devices in this family have a Class I recall. 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (26)

See all 26

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K031935	Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and TMS-2530	Tiara Medical Systems, Inc.	2004	23
K034053	TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040	Tiara Medical Systems, Inc.	2004	1
K093124	Puresom Nasal Mask-Small, Puresom Nasal Mask-Medium, Puresom Nasal Mask-Large, Models…	Cardinal Health 207, Inc.	2010	0

Has anything in its family been recalled? (8 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K132887Airfit N10Resmed, Ltd. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
K081743Classicstar NV SE and Novastar NV SE and Aav Full Face MasksDraeger Medical AG & Co. KG · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
K120463Mojo, VerasealSleepnet Corporation · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented…Sleepnet Corporation · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
K190254Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskSleepnet Corporation · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
K161978AirFit N20Resmed, Ltd. · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
K171212AirFit N20Resmed, Ltd. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall

Nearest 5 of 8; all are on the web page.

What does this lineage say?

Of its descendants, K031935 (Tiara Medical Systems, Inc., 2004) has gone furthest, with 23 descendants of its own.

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?

The Tiara Medical Systems Advantage™ Nasal Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure), operating at or above 3 cmH,0 for the treatment of adult obstructive sleep apnea.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012207 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012207: Advantage Nasal Mask, Small, Advantage Nasal Mask. Regular, Models TMS-2520, TMS 2530.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012207

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026