510(k) · Cleared

Recalled · Class I · 2022

Revolutionfull Face Mask

K082866510(k) TraditionalCleared Jan 30, 2009123-day reviewClass II21 CFR 868.5905Recalls 1 (1 Class I)

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

Respironics Inc., Sleep & Home Respiratory Group · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Jan 30, 2009 as substantially equivalent to K073600 (Respironics Inc., Sleep & Home Respiratory Group, 2008) and 1 other predicate after a 123-day review. Its family tree reaches back 2 generations to 1999. 2 of the 8 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.

Decided: Jan 30, 2009
Review: 123 days
Class: Class II
Product code: BZD
Recalls: 1 (1 Class I)
Predicates: 2

Its longest line of descent runs back 2 generations to K984428 (1999). 5 ancestors in all, the oldest K954207 (1996). 2 later devices descend from it, 2 citing it directly. 2 of the 8 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK984428 Sullivan Autoset Nasal Cpap SystemResmed, Ltd. · 1999
1 generation backK023068 Papillon Mask SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2003
This deviceK082866 Revolutionfull Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009
Descendant · cites it directly · 0 of its ownK140580 Revolution Fullface MaskRespironics Inc. (Dba Philips Respironics) · 2015
Descendant · cites it directly · 0 of its ownK142554 Revolution Full Face MaskRespironics, Inc. · 2015 · Recalled (Class I)

Class I recalls in this family

K142554 Revolution Full Face Maskcites it directly · 2015

Most influential descendants

Showing 2 of 2 · See all

K140580Revolution Fullface MaskRespironics Inc. (Dba Philips Respironics) · 2015 · cites it directly0descendants
K142554Revolution Full Face MaskRespironics, Inc. · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K984428	Sullivan Autoset Nasal Cpap System	Resmed, Ltd.	1999	—
−1	K023068	Papillon Mask Set	Map Medizintechnik Fur Arzt Und Patient GmbH	2003	—
0 (this device)	K082866	Revolutionfull Face Mask	Respironics Inc., Sleep & Home Respiratory Group	2009	—
+1	K140580	Revolution Fullface Mask	Respironics Inc. (Dba Philips Respironics)	2015	—
+1	K142554	Revolution Full Face Mask	Respironics, Inc.	2015	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2000	1	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	2	1

FIG. 1 — Lineage of K082866, 1999–2015Source: 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.

2 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

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What was it cleared against? (2)

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
*	K073600	Comfortgel Full Face Mask Summary page 1 …uous, non-life supporting Proprietary Name Respironics RevolutionFull Face Mask Predicate Device(s) Respironics ComfortGel Full Face Mask (K073600) - BZD MAP Medizintechnik Fur ARZT UND Papillon Mask Set (K023068) - BZD Reason for submission…	Respironics Inc., Sleep & Home Respiratory Group	2008	—
*	K023068	Papillon Mask Set Summary page 1 …redicate Device(s) Respironics ComfortGel Full Face Mask (K073600) - BZD MAP Medizintechnik Fur ARZT UND Papillon Mask Set (K023068) - BZD Reason for submission New device Substantial Equivalence The Respironics RevolutionFull Face Mask has t…	Map Medizintechnik Fur Arzt Und Patient GmbH	2003	—

Also cleared against K073600: 3 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K140580	Revolution Fullface Mask	Respironics Inc. (Dba Philips Respironics)	2015	0
K142554	Revolution Full Face Mask Class I	Respironics, Inc.	2015	0

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 6, 2022	Class I	Z-1780-2022	Error in labeling	No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

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.

K142554Revolution Full Face MaskRespironics, Inc. · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
1 of the 5 ancestors has a recall of any class.
Of its descendants, K140580 (Respironics Inc. (Dba Philips Respironics), 2015) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K073600.

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. 2009, this device’s year, is highlighted.

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 Revolution Full Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is intended for single patient reuse in the home and multi-patient, multi-use in the hospitalinstitutional environment. The mask is to be used on patients (>661bs/30kg) for whom CPAP or bi-level therapy has been prescribed.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082866 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082866: Revolutionfull Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082866

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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