510(k) · Cleared

Recalled · Class I · 2022

Magneto Nasal Mask

K210386510(k) TraditionalCleared Jul 12, 2021153-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. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Jul 12, 2021 as substantially equivalent to K140268 (Respironics, Inc., 2014) after a 153-day review. Its family tree reaches back 1 generation to 2014. 2 of the 3 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once, including a Class I recall.

Decided: Jul 12, 2021
Review: 153 days
Class: Class II
Product code: BZD
Recalls: 1 (1 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to K140268 (2014). 1 later device descends from it, 1 citing it directly. 2 of the 3 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK140268 Simple T Youth Nasal MaskRespironics, Inc. · 2014 · Recalled (Class I)
This deviceK210386 Magneto Nasal MaskRespironics, Inc. · 2021
Descendant · cites it directly · 0 of its ownK231313 Therapy Mask 3100 NC/SPRespironics, Inc. · 2023

Class I recalls in this family

K140268 Simple T Youth Nasal Maskdirect predicate · 2014

Most influential descendants

Showing 1 of 1 · See all

K231313Therapy Mask 3100 NC/SPRespironics, Inc. · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K140268	Simple T Youth Nasal Mask	Respironics, Inc.	2014	Class I
0 (this device)	K210386	Magneto Nasal Mask	Respironics, Inc.	2021	—
+1	K231313	Therapy Mask 3100 NC/SP	Respironics, Inc.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0

FIG. 1 — Lineage of K210386, 2014–2023Source: 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
*	K140268	Simple T Youth Nasal Mask Summary page 4 …CFR 868.5905 Classification Name/Product Code Ventilator, non-continuous (respirator)/BZD Predicate Device Simple T Youth Nasal Mask (K140268) Respironics Inc. 1 Magneto Nasal Ma…	Respironics, Inc.	2014	Class I

Also cleared against K140268: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K231313	Therapy Mask 3100 NC/SP	Respironics, Inc.	2023	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-1784-2022	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.

K140268Simple T Youth Nasal MaskRespironics, Inc. · 2014 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has a recall, Class I.
Of its descendants, K231313 (Respironics, Inc., 2023) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K140268.

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. 2021, 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?

This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients > 7 years old (>40 Ibs) for whom CPAP or bi-level therapy has been prescribed.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K210386 · printed Nov 6, 2026

Cite this page

510(k) Report. “K210386: Magneto Nasal Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210386

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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