510(k) · Cleared
ClearedAerochamber Plus Valved Holding Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trudell Medical Int'L · CAF Nebulizer (Direct Patient Interface)
Cleared on Sep 14, 1999 after a 15-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Sep 14, 1999
- Review
- 15 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK992917 Aerochamber Plus Valved Holding ChamberTrudell Medical Int'L · 1999
- Descendant · cites it directly · 0 of its ownK100285 Litetouch MaskRespironics New Jersey, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK080100 WatchhalerActivaero America, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK032809 Hospital SpacerRespironics Healthscan, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK020944 Vortex Valved Holding ChamberPari Innovative Manufacturers, Inc. · 2002
Most influential descendants
Showing 4 of 4 · See all- K100285Litetouch MaskRespironics New Jersey, Inc. · 2010 · cites it directly0descendants
- K080100WatchhalerActivaero America, Inc. · 2008 · cites it directly0descendants
- K032809Hospital SpacerRespironics Healthscan, Inc. · 2003 · cites it directly0descendants
- K020944Vortex Valved Holding ChamberPari Innovative Manufacturers, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992917 | Aerochamber Plus Valved Holding Chamber | Trudell Medical Int'L | 1999 | — |
| +1 | K100285 | Litetouch Mask | Respironics New Jersey, Inc. | 2010 | — |
| +1 | K080100 | Watchhaler | Activaero America, Inc. | 2008 | — |
| +1 | K032809 | Hospital Spacer | Respironics Healthscan, Inc. | 2003 | — |
| +1 | K020944 | Vortex Valved Holding Chamber | Pari Innovative Manufacturers, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K100285 (Respironics New Jersey, Inc., 2010) has gone furthest, with 0 descendants 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 “AeroChamber® Pjus Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care professional or physician. The device is intended to by used by these patients to administer aerosolized medication from most pressurized Metered Dose. [nhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
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/K992917 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992917: Aerochamber Plus Valved Holding Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992917
Report an extraction error
Are you the manufacturer?
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