510(k) · Cleared

Cleared

Nasal Aire

K990659510(k) TraditionalCleared Nov 26, 1999270-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

Breathing Technologies Corp. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Nov 26, 1999 as substantially equivalent to K945938 (Respironics, Inc., 1996) after a 270-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.

Decided: Nov 26, 1999
Review: 270 days
Class: Class II
Product code: BZD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K945938 (1996). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK945938 Respironics Monarch Mini MaskRespironics, Inc. · 1996
This deviceK990659 Nasal AireBreathing Technologies Corp. · 1999
Descendant · cites it directly · 1 of its ownK034053 TMS Snapp Soft Nasal Accessory for Positive Pressure, Models…Tiara Medical Systems, Inc. · 2004
Descendant · 2 generations on · 0 of its ownK051583 Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models…Tiara Medical Systems, Inc. · 2005

Most influential descendants

Showing 2 of 2 · See all

K034053TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040Tiara Medical Systems, Inc. · 2004 · cites it directly1descendant
K051583Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030…Tiara Medical Systems, Inc. · 2005 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945938	Respironics Monarch Mini Mask	Respironics, Inc.	1996	—
0 (this device)	K990659	Nasal Aire	Breathing Technologies Corp.	1999	—
+1	K034053	TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020…	Tiara Medical Systems, Inc.	2004	—
+2	K051583	Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models TMS-3020…	Tiara Medical Systems, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0

FIG. 1 — Lineage of K990659, 1996–2005Source: 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? (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
*	K945938	Respironics Monarch Mini Mask Summary page 1 …ry (classification names) Nasal-Aire™ (proprietary trade name) Predicate Device: The Monarch® Mini Mask manufactured by Respironics, Inc. Cleared for market by 510(k) #K945938 indications for Use and Description of Subject Device: Nasal-Aire is intended for use as an accessory to respiratory ventilator…	Respironics, Inc.	1996	—

Also cleared against K945938: 2 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
K034053	TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040	Tiara Medical Systems, Inc.	2004	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?

Its one ancestor has no recall.
Of its descendants, K034053 (Tiara Medical Systems, Inc., 2004) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K945938.

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?

Nasal Aire is an accessory to positive pressure ventilation devices (e.g. CPAP, Bi-level).

It may also be used in respiratory insufficiencies if the patient can tolerate the excess

dead space.

The Nasal-Aire cannot exhaust exhaled air therefore this device must be used with a

ventilator that contains an active exhalation valve or with an intentional leak port added

into the breathing circuit

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/K990659 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990659: Nasal Aire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990659

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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