510(k) · Cleared
ClearedOptichamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthscan Products, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Oct 17, 1996 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Oct 17, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK962822 OptichamberHealthscan Products, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK042546 Funhaler, Model FH 101Infamed, Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK110136 Respichamber Valved Holding ChamberTrudell Medical Intl. · 2011
- Descendant · 2 generations on · 0 of its ownK080100 WatchhalerActivaero America, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK072822 Funhaler, Model V-201EInfamed, Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK072418 Optichamber Advantage Anti-Static Valved Holding ChamberRespironics New Jersey, Inc. · 2007
Most influential descendants
Showing 5 of 5 · See all- K042546Funhaler, Model FH 101Infamed, Ltd. · 2005 · cites it directly2descendants
- K110136Respichamber Valved Holding ChamberTrudell Medical Intl. · 2011 · cites it directly0descendants
- K080100WatchhalerActivaero America, Inc. · 2008 · 2 generations on0descendants
- K072822Funhaler, Model V-201EInfamed, Ltd. · 2007 · 2 generations on0descendants
- K072418Optichamber Advantage Anti-Static Valved Holding ChamberRespironics New Jersey, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962822 | Optichamber | Healthscan Products, Inc. | 1996 | — |
| +1 | K042546 | Funhaler, Model FH 101 | Infamed, Ltd. | 2005 | — |
| +1 | K110136 | Respichamber Valved Holding Chamber | Trudell Medical Intl. | 2011 | — |
| +2 | K080100 | Watchhaler | Activaero America, Inc. | 2008 | — |
| +2 | K072822 | Funhaler, Model V-201E | Infamed, Ltd. | 2007 | — |
| +1 | K072418 | Optichamber Advantage Anti-Static Valved Holding Chamber | Respironics New Jersey, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
3 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, K042546 (Infamed, Ltd., 2005) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K962822 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962822: Optichamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962822
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026