510(k) · Cleared
ClearedLitetouch Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics New Jersey, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jun 29, 2010 as substantially equivalent to K032972 (Trudell Medical Intl., 2004) and 1 other predicate after a 148-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jun 29, 2010
- Review
- 148 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K992917 (1999). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK992917 Aerochamber Plus Valved Holding ChamberTrudell Medical Int'L · 1999
- This deviceK100285 Litetouch MaskRespironics New Jersey, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992917 | Aerochamber Plus Valved Holding Chamber | Trudell Medical Int'L | 1999 | — |
| 0 (this device) | K100285 | Litetouch Mask | Respironics New Jersey, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
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 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? (2)
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 |
|---|---|---|---|
| * | K032972 | Aerochamber Max Valved Holding ChamberSummary page 2…mation: Identification of legally marketed device which we claim substantial equivalence to: AeroChamber Max Valved Holding Chamber Small and Medium Mask K032972 AeroChamber Plus Valved Holding Chamber (K99291 7) Trudell Medical International. 725 Third Street London, On… | 2004 |
| * | K992917 | Aerochamber Plus Valved Holding ChamberSummary page 2…e which we claim substantial equivalence to: AeroChamber Max Valved Holding Chamber Small and Medium Mask K032972 AeroChamber Plus Valved Holding Chamber (K99291 7) Trudell Medical International. 725 Third Street London, Ontario Canada, N5V 504 4. Device Description:… | 1999 |
| † | K962822 | Optichamber | 1996 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 LiteTouch medium mask for ages 1-5 is to be used with OptiChamber Advantage Valved Holding Chambers. The mask is intended to be used to help administer aerosolized medication from most pressurized metered dose inhalers used with valved holding chambers as prescribed by a physician or health care professional. The intended environments for use include homes, hospitals, and clinics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100285: Litetouch Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100285
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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