510(k) · Cleared
ClearedLiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thayer Medical Corporation · NVP Holding Chambers, Direct Patient Interface
Cleared on Apr 1, 2022 as substantially equivalent to K160109 (Thayer Medical Corporation, 2017) after a 400-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Apr 1, 2022
- Review
- 400 days
- Class
- Class II
- Product code
- NVP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K993101 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK993101 LiteaireThayer Medical Corp. · 2000
- 1 generation backK160109 Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding ChamberThayer Medical Corporation · 2017
- This deviceK210558 LiteAire Basic Dual-Valved, Collapsible MDI Holding ChamberThayer Medical Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993101 | Liteaire | Thayer Medical Corp. | 2000 | — |
| −1 | K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber | Thayer Medical Corporation | 2017 | — |
| 0 (this device) | K210558 | LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber | Thayer Medical Corporation | 2022 | — |
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 NVP? 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 NVP device
- #1 K242667 AeroChamber2go Anti-Static Valved Holding…score 9.0 · 2 generations · no Class I recall
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 | Decided |
|---|---|---|---|
| * | K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding ChamberSummary page 4…ing Chambers, Direct Patient Interface Name of the Predicate Device Thayer Medical LiteAire® Dual-Valved, Collapsible MDI Holding Chamber (K160109) 1.1 Device Description The LiteAire® BASIC Dual Valved, Collapsible MDI Holding Chamber (also referred to as the LiteAire®… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 2 companies; a new generation was cleared every 16.6 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All NVP devicesNVP Holding Chambers, Direct Patient Interface: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NVP
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NVP
235in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NVP
No recall names NVP since 2007.
Adverse event reports per year · NVP
3in 2024
MAUDE reports naming product code NVP, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 235 | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LiteAire is a collapsible, disposable dual-valved holding chamber designed to aid in the delivery of aerosolized medications delivered via a pressurized metered dose inhaler (MDI).
The LiteAire features a standard port designed for compatibility with standard MDI mouthpieces. It is a non-sterile device for single-patient use.
The LiteAire is intended to be used by adults, adolescents and children ages 5 and up who are able to use a holding chamber without the aid of a mask and who are under the care or treatment of a physician or licensed healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210558: LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210558
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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