510(k) · Cleared

Cleared

TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840

K043382510(k) TraditionalCleared Jan 19, 200541-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 Jan 19, 2005 as substantially equivalent to K031935 (Tiara Medical Systems, Inc., 2004) and 2 other predicates after a 41-day review. Its family tree reaches back 3 generations to 1995. 8 of the 30 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it.

Decided: Jan 19, 2005
Review: 41 days
Class: Class II
Product code: BZD
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K936047 (1995). 8 ancestors in all. 21 later devices descend from it, 1 citing it directly. 8 of the 30 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK936047 Spectrum (TM) MaskRespironics, Inc. · 1995
2 generations backK961915 Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, LargeRespironics, Inc. · 1996
1 generation backK020759 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large…Hans Rudolph, Inc. · 2002
This deviceK043382 TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc. · 2005
Descendant · cites it directly · 20 of its ownK060273 Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model…Sleepnet Corporation · 2006
Descendant · 2 generations on · 7 of its ownK132887 Airfit N10Resmed, Ltd. · 2013 · Recalled (Class I)
Descendant · 3 generations on · 6 of its ownK153673 AirFit N20Resmed, Ltd. · 2016
Descendant · 2 generations on · 6 of its ownK063806 Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · Recalled (Class I)
Descendant · 4 generations on · 5 of its ownK161978 AirFit N20Resmed, Ltd. · 2016 · Recalled (Class I)

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2006high 3 (2024) · low 0 (2009)2026

Class I recalls in this family

K132887 Airfit N102 generations on · 2013
K063806 Sleepnet Mojo -NV Full Face Mask, Non-Vented2 generations on · 2007
K081743 Classicstar NV SE and Novastar NV SE and Aav…2 generations on · 2008
K120463 Mojo, Veraseal2 generations on · 2012

Most influential descendants

Showing 5 of 21 · See all

K060273Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model…Sleepnet Corporation · 2006 · cites it directly20descendants
K132887Airfit N10Resmed, Ltd. · 2013 · 2 generations on7descendants
K153673AirFit N20Resmed, Ltd. · 2016 · 3 generations on6descendants
K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · 2 generations on6descendants
K161978AirFit N20Resmed, Ltd. · 2016 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K936047	Spectrum (TM) Mask	Respironics, Inc.	1995	—
−2	K961915	Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large	Respironics, Inc.	1996	—
−1	K020759	7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630…	Hans Rudolph, Inc.	2002	—
0 (this device)	K043382	TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840	Tiara Medical Systems, Inc.	2005	—
+1	K060273	Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model…	Sleepnet Corporation	2006	—
+2	K132887	Airfit N10	Resmed, Ltd.	2013	Class I
+3	K153673	AirFit N20	Resmed, Ltd.	2016	—
+2	K063806	Sleepnet Mojo -NV Full Face Mask, Non-Vented	Sleepnet Corporation	2007	Class I
+4	K161978	AirFit N20	Resmed, Ltd.	2016	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
2000	1	0
2001	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	1
2008	1	1
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 K043382, 1995–2026Source: 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.

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? (3)

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
*	K031935	Tiara Medical Systems Advantage II Nasal Mask, Models TMS-2520 and TMS-2530 Summary page 1 …evice Common Name: Nasal Mask Classification Name: Ventilator, Noncontinuous (Respirator), 73BZD Predicate devices: TMS Advantage II, K031935, Hans Rudolph 7600 Series Reusable Full -Face CPAP/NIPPV Mask, K020759, Respironics Spectrum 2 Re…	Tiara Medical Systems, Inc.	2004	—
*	K020759	7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640… Summary page 1 …spirator), 73BZD Predicate devices: TMS Advantage II, K031935, Hans Rudolph 7600 Series Reusable Full -Face CPAP/NIPPV Mask, K020759, Respironics Spectrum 2 Reusable Full-Face Mask, K002465 Reason for submission: This dev…	Hans Rudolph, Inc.	2002	—
*	K002465	Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876 Summary page 1 …7600 Series Reusable Full -Face CPAP/NIPPV Mask, K020759, Respironics Spectrum 2 Reusable Full-Face Mask, K002465 Reason for submission: This device has not been previously marketed in the USA. Device Description: The Tiara Medical Sy…	Respironics, Inc.	2000	—

Also cleared against K031935: 1 other device →

What descends from it? (21)

See all 21

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060273	Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model…	Sleepnet Corporation	2006	20

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 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · 2 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 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
K120463Mojo, VerasealSleepnet Corporation · 2012 · 2 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 · 3 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 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
K161978AirFit N20Resmed, Ltd. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
K171212AirFit N20Resmed, Ltd. · 2017 · 5 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?

The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
None of the 8 ancestors has a recall.
Of its descendants, K060273 (Sleepnet Corporation, 2006) has gone furthest, with 20 descendants of its own.
1 other device also cites its predicate K031935.

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 FULL ADVANTAGETM Full Face Mask is intended to

be used with positive airway pressure devices such as CPAP (Continuous

Positive Airway Pressure) for the treatment of adult obstructive sleep apnea.

The mask is intended for single patient use and re-use in the home or

hospital/institutional environment. The mask is to be used on adult patients

(>30kg) for whom positive airway pressure therapy has been prescribed.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043382 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043382: TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043382

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