510(k) · Cleared

Cleared

Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876

K002465510(k) SpecialCleared Sep 8, 200028-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

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

Cleared on Sep 8, 2000 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 of the 76 devices in its family, counting itself, have a Class I recall. 75 later devices descend from it.

Decided: Sep 8, 2000
Review: 28 days
Class: Class II
Product code: BZD
Recalls: None
Predicates: 0

75 later devices descend from it, 10 citing it directly. 13 of the 76 devices in this family, counting this one, have a Class I recall.

This deviceK002465 Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876Respironics, Inc. · 2000
Descendant · cites it directly · 28 of its ownK023135 IMAGE3 SE Disposable Full Face MaskRespironics, Inc. · 2003
Descendant · cites it directly · 21 of its ownK043382 TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc. · 2005
Descendant · cites it directly · 20 of its ownK073600 Comfortgel Full Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2008
Descendant · 2 generations on · 20 of its ownK060273 Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model…Sleepnet Corporation · 2006
Descendant · 2 generations on · 10 of its ownK092835 Comfortgel Nasal MaskRespironics Inc., Sleep & Home Respiratory Group · 2010

Showing 5 of 75 descendants. See all descendants

Descendants cleared per year

2003high 7 (2015) · low 0 (2004)2026

Class I recalls in this family

K063268 Cpap/Vpap Masks, Models 1225, 1205 and 1235cites it directly · 2007
K081743 Classicstar NV SE and Novastar NV SE and Aav…2 generations on · 2008
K082866 Revolutionfull Face Mask2 generations on · 2009
K132887 Airfit N103 generations on · 2013

Most influential descendants

Showing 5 of 75 · See all

K023135IMAGE3 SE Disposable Full Face MaskRespironics, Inc. · 2003 · cites it directly28descendants
K043382TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840Tiara Medical Systems, Inc. · 2005 · cites it directly21descendants
K073600Comfortgel Full Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2008 · cites it directly20descendants
K060273Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model…Sleepnet Corporation · 2006 · 2 generations on20descendants
K092835Comfortgel Nasal MaskRespironics Inc., Sleep & Home Respiratory Group · 2010 · 2 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002465	Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876	Respironics, Inc.	2000	—
+1	K023135	IMAGE3 SE Disposable Full Face Mask	Respironics, Inc.	2003	—
+1	K043382	TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840	Tiara Medical Systems, Inc.	2005	—
+1	K073600	Comfortgel Full Face Mask	Respironics Inc., Sleep & Home Respiratory Group	2008	—
+2	K060273	Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model…	Sleepnet Corporation	2006	—
+2	K092835	Comfortgel Nasal Mask	Respironics Inc., Sleep & Home Respiratory Group	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	2	0
2006	3	0
2007	5	2
2008	5	1
2009	4	1
2010	4	0
2011	5	0
2012	5	1
2013	2	1
2014	1	0
2015	7	2
2016	3	1
2017	4	2
2018	2	0
2019	3	2
2020	2	0
2021	4	0
2023	1	0
2024	6	0
2025	2	0
2026	4	0

FIG. 1 — Lineage of K002465, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

13 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (75)

See all 75

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

Number	Device	Applicant	Decided	Descendants
K023135	IMAGE3 SE Disposable Full Face Mask	Respironics, Inc.	2003	28
K043382	TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840	Tiara Medical Systems, Inc.	2005	21
K073600	Comfortgel Full Face Mask	Respironics Inc., Sleep & Home Respiratory Group	2008	20
K063268	Cpap/Vpap Masks, Models 1225, 1205 and 1235 Class I	Hsiner Co., Ltd.	2007	4
K103174	Apex Medical Wizard Series Cpap Mask	Apex Medical Corp.	2011	3
K101130	Bipap Synchrony 2 with AF531 Full Face Mask	Respironics, Inc.	2010	1
K071149	Hri 6500, 6600 and 6700 Series V2MASKS	Hans Rudolph, Inc.	2008	1
K071915	Cpap Mask	Arcimed Laboratories, LLC	2008	0
K070321	Twilight Full Face Mask	Invacare Corp.	2007	0
K052249	Utopia	Respcare, Inc.	2005	0

Has anything in its family been recalled? (13 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.

K063268Cpap/Vpap Masks, Models 1225, 1205 and 1235Hsiner Co., Ltd. · 2007 · Cites it directly · ◆ 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
K082866Revolutionfull Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
K132887Airfit N10Resmed, Ltd. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
K120463Mojo, VerasealSleepnet Corporation · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 112 Class I recalls
K142554Revolution Full Face MaskRespironics, Inc. · 2015 · 3 generations on · ◆ in the 2015 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 · 4 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 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
K140980TI Nasal MaskRespironics, Inc. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K161978AirFit N20Resmed, Ltd. · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

Nearest 12 of 13 shown.

Nearest 5 of 13; all are on the web page.

What does this lineage say?

Of its descendants, K023135 (Respironics, Inc., 2003) has gone furthest, with 28 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)	—

https://510kreport.com/device/K002465 · printed Nov 5, 2026

Cite this page

510(k) Report. “K002465: Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002465

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026