510(k) · Cleared
ClearedLiteaire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thayer Medical Corp. · CAF Nebulizer (Direct Patient Interface)
Cleared on Oct 26, 2000 after a 406-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Oct 26, 2000
- Review
- 406 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK993101 LiteaireThayer Medical Corp. · 2000
- Descendant · cites it directly · 1 of its ownK160109 Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding ChamberThayer Medical Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK210558 LiteAire Basic Dual-Valved, Collapsible MDI Holding ChamberThayer Medical Corporation · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993101 | Liteaire | Thayer Medical Corp. | 2000 | — |
| +1 | K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber | Thayer Medical Corporation | 2017 | — |
| +2 | K210558 | LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber | Thayer Medical Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAF? 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 CAF device
- #1 K260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)score 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber | 2017 | 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?
- Of its descendants, K160109 (Thayer Medical Corporation, 2017) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAF
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAF
1in 2018
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · CAF
191in 2025
MAUDE reports naming product code CAF, 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 | 18 | 98 | 1 | 26 |
| 2008 | 12 | 123 | 0 | 11 |
| 2009 | 8 | 163 | 0 | 15 |
| 2010 | 10 | 114 | 0 | 37 |
| 2011 | 10 | 157 | 1 | 237 |
| 2012 | 9 | 126 | 0 | 138 |
| 2013 | 9 | 238 | 0 | 217 |
| 2014 | 9 | 151 | 5 | 123 |
| 2015 | 8 | 186 | 3 | 166 |
| 2016 | 5 | 186 | 1 | 201 |
| 2017 | 8 | 253 | 14 (13) | 256 |
| 2018 | 9 | 161 | 1 | 162 |
| 2019 | 3 | 266 | 0 | 185 |
| 2020 | 6 | 219 | 0 | 117 |
| 2021 | 8 | 324 | 0 | 161 |
| 2022 | 4 | 176 | 0 | 55 |
| 2023 | 8 | 279 | 0 | 107 |
| 2024 | 4 | 251 | 0 | 102 |
| 2025 | 7 | 211 | 0 | 191 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The LiteAire is a collapsible, disposable accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The LiteAire is a dual-valved holding chamber designed to serve three-major functions: e To reduce the amount of MDI medication deposited in the patient’s mouth and throat, thus reducing the potential for unwanted…
Read the full statement (128 words)
The LiteAire is a collapsible, disposable accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces.
The LiteAire is a dual-valved holding chamber designed to serve three-major functions:
e To reduce the amount of MDI medication deposited in the patient’s mouth and throat, thus reducing the potential for unwanted local or systemic side effects.
¢ To ease the problems that many patients have in synchronizing actuation of the MDI canister with the start of inhalation.
o To retain a significant portion of the MDI drug plume until the patient’s next inhalation, in cases where actuation and inhalation are asynchronous.
The LiteAire is a non-sterile device for single-patient use.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993101 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993101: Liteaire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993101
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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