510(k) · Cleared

Cleared

Therapy Mask 3100 NC/SP

K231313510(k) SpecialCleared Jul 28, 202384-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 Jul 28, 2023 as substantially equivalent to K210386 (Respironics, Inc., 2021) after an 84-day review. Its family tree reaches back 2 generations to 2014. 2 of the 3 devices in its family, counting itself, have a Class I recall.

Decided: Jul 28, 2023
Review: 84 days
Class: Class II
Product code: BZD
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K140268 (2014). No later device cites it as a predicate yet. 2 of the 3 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK140268 Simple T Youth Nasal MaskRespironics, Inc. · 2014 · Recalled (Class I)
1 generation backK210386 Magneto Nasal MaskRespironics, Inc. · 2021 · Recalled (Class I)
This deviceK231313 Therapy Mask 3100 NC/SPRespironics, Inc. · 2023

Class I recalls in this family

K210386 Magneto Nasal Maskdirect predicate · 2021
K140268 Simple T Youth Nasal Mask2 generations back · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K140268	Simple T Youth Nasal Mask	Respironics, Inc.	2014	Class I
−1	K210386	Magneto Nasal Mask	Respironics, Inc.	2021	Class I
0 (this device)	K231313	Therapy Mask 3100 NC/SP	Respironics, Inc.	2023	—

FIG. 1 — Lineage of K231313, 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
*	K210386	Magneto Nasal Mask Summary page 4 …21 CFR 868.5905 Classification Name/Product Code Ventilator, non-continuous (respirator)/BZD Predicate Device Therapy Mask 3100 NC/SP (K210386) Respironics Inc. 1 CBE Special 510(k)…	Respironics, Inc.	2021	Class I

What descends from it?

No later submission names this one as a predicate yet.

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.

K210386Magneto Nasal MaskRespironics, Inc. · 2021 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K140268Simple T Youth Nasal MaskRespironics, Inc. · 2014 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 6.7 years on median.
2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.

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. 2023, 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 lbs) for whom CPAP or bi-level therapy has been prescribed.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K231313 · printed Nov 6, 2026

Cite this page

510(k) Report. “K231313: Therapy Mask 3100 NC/SP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231313

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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