510(k) · Cleared

Cleared

Soyala Full Face Mask

K061653510(k) TraditionalCleared Nov 9, 2006149-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

Weinmann Gerate Fur Medizin GmbH + Co. KG · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Nov 9, 2006 as substantially equivalent to K023244 (Resmed, Ltd., 2002) and 3 other predicates after a 149-day review. Its family tree reaches back 4 generations to 1983. 2 later devices descend from it.

Decided: Nov 9, 2006
Review: 149 days
Class: Class II
Product code: BZD
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K833786 (1983). 14 ancestors in all. 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
3 generations backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
2 generations backK991648 Reusable Contour II Nasal MaskRespironics, Inc. · 1999
1 generation backK013738 Weinmann SomnomaskGottlieb Weinmann Geraete Fuer Medizin Und Arbeits · 2002
This deviceK061653 Soyala Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG · 2006
Descendant · cites it directly · 1 of its ownK073673 Soyala Full Face Mask Gel VentedWeinmann Gerate Fur Medizin GmbH + Co. KG · 2008
Descendant · 2 generations on · 0 of its ownK112167 Soyala Silkgel Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG · 2011

Most influential descendants

Showing 2 of 2 · See all

K073673Soyala Full Face Mask Gel VentedWeinmann Gerate Fur Medizin GmbH + Co. KG · 2008 · cites it directly1descendant
K112167Soyala Silkgel Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG · 2011 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K833786	Microprocessor Ventilator 7200	Puritan Bennett Corp.	1983	—
−3	K951264	Bipap Model S/T-D	Respironics, Inc.	1996	—
−2	K991648	Reusable Contour II Nasal Mask	Respironics, Inc.	1999	—
−1	K013738	Weinmann Somnomask	Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits	2002	—
0 (this device)	K061653	Soyala Full Face Mask	Weinmann Gerate Fur Medizin GmbH + Co. KG	2006	—
+1	K073673	Soyala Full Face Mask Gel Vented	Weinmann Gerate Fur Medizin GmbH + Co. KG	2008	—
+2	K112167	Soyala Silkgel Full Face Mask	Weinmann Gerate Fur Medizin GmbH + Co. KG	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1998	1	0
1999	1	0
2000	1	0
2001	1	0
2002	1	0
2003	1	0
2004	2	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	1	0

FIG. 1 — Lineage of K061653, 1983–2011Source: 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.

Planning a device in BZD? 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? (4)

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
*	K023244	Mirage Full Face Mask Series 2 Summary page 1 …11,Product Code BZD Predicate Device Equivalence: Substantial equivalence is claimed to ResMed Mirage Full Face Mask Series 2, cleared for commercial distribution per K023244, Weinmann SOMNOmnask, K01 3738, Weinmann SOYALA, K060405, and Fisher & Paykel Flexifit Series HC431 Full Face Mask, K040506.…	Resmed, Ltd.	2002	—
*	K013738	Weinmann Somnomask Summary page 1 …e Device Equivalence: Substantial equivalence is claimed to ResMed Mirage Full Face Mask Series 2, cleared for commercial distribution per K023244, Weinmann SOMNOmnask, K01 3738, Weinmann SOYALA, K060405, and Fisher & Paykel Flexifit Series HC431 Full Face Mask, K040506.…	Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits	2002	—
*	K060405	Soyala, Soyala Blue Cleared while this submission was under review Summary page 1 …tantial equivalence is claimed to ResMed Mirage Full Face Mask Series 2, cleared for commercial distribution per K023244, Weinmann SOMNOmnask, K01 3738, Weinmann SOYALA, K060405, and Fisher & Paykel Flexifit Series HC431 Full Face Mask, K040506. 5-1…	Weinmann Gerate Fur Medizin GmbH + Co. KG	2006	—
*	K040506	Flexifil Series HC431 Full Face Mask, Model HC431A Summary page 1 …es 2, cleared for commercial distribution per K023244, Weinmann SOMNOmnask, K01 3738, Weinmann SOYALA, K060405, and Fisher & Paykel Flexifit Series HC431 Full Face Mask, K040506. 5-1 WE…	Fisher & Paykel Healthcare, Ltd.	2004	6

Also cleared against K023244: 11 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K073673	Soyala Full Face Mask Gel Vented	Weinmann Gerate Fur Medizin GmbH + Co. KG	2008	1

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
3 of the 14 ancestors have a recall of any class.
Of its descendants, K073673 (Weinmann Gerate Fur Medizin GmbH + Co. KG, 2008) has gone furthest, with 1 descendant of its own.
11 other devices also cite its predicate K023244.

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 SOYALA Full Face Mask is intended for adult patients (>30kg) prescribed continuous positive airway pressure (CPAP) or bi-level therapy for multiple-patient use in a hospital or clinic environment after high-level disinfection and for single-patient use in a home environment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061653 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061653: Soyala Full Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061653

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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