510(k) · Cleared

Cleared

Papillon Mask Set

K023068510(k) TraditionalCleared May 28, 2003254-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

Map Medizintechnik Fur Arzt Und Patient GmbH · BZD Ventilator, Non-Continuous (Respirator)

Cleared on May 28, 2003 as substantially equivalent to K984428 (Resmed, Ltd., 1999) after a 254-day review. Its family tree reaches back 1 generation to 1999. 2 of the 5 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.

Decided: May 28, 2003
Review: 254 days
Class: Class II
Product code: BZD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K984428 (1999). 3 later devices descend from it, 1 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK984428 Sullivan Autoset Nasal Cpap SystemResmed, Ltd. · 1999
This deviceK023068 Papillon Mask SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2003
Descendant · cites it directly · 2 of its ownK082866 Revolutionfull Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
Descendant · 2 generations on · 0 of its ownK140580 Revolution Fullface MaskRespironics Inc. (Dba Philips Respironics) · 2015
Descendant · 2 generations on · 0 of its ownK142554 Revolution Full Face MaskRespironics, Inc. · 2015 · Recalled (Class I)

Class I recalls in this family

K082866 Revolutionfull Face Maskcites it directly · 2009
K142554 Revolution Full Face Mask2 generations on · 2015

Most influential descendants

Showing 3 of 3 · See all

K082866Revolutionfull Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009 · cites it directly2descendants
K140580Revolution Fullface MaskRespironics Inc. (Dba Philips Respironics) · 2015 · 2 generations on0descendants
K142554Revolution Full Face MaskRespironics, Inc. · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	1
2015	2	1

FIG. 1 — Lineage of K023068, 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? (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
*	K984428	Sullivan Autoset Nasal Cpap System Summary page 1 …l mask Proprietary Name Papillon@Mask Set Predicate Device Sullivan@MirageTM Mask System (K984428) Reason for submission New Device page 8 of 30 1.2.2 Substantia…	Resmed, Ltd.	1999	—

Also cleared against K984428: 5 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K082866	Revolutionfull Face Mask Class I	Respironics Inc., Sleep & Home Respiratory Group	2009	2

Has anything in its family been recalled? (2 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.

K082866Revolutionfull Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
K142554Revolution Full Face MaskRespironics, Inc. · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K082866 (Respironics Inc., Sleep & Home Respiratory Group, 2009) has gone furthest, with 2 descendants of its own.
5 other devices also cite its predicate K984428.

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 Papillon Mask Set is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure), operating at or above 4 cm H₂O for the treatment of adult obstructive sleep apnea. The mask is single patient reusable:

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023068 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023068: Papillon Mask Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023068

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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