510(k) · Cleared
ClearedWatchhaler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Activaero America, Inc. · NVP Holding Chambers, Direct Patient Interface
Cleared on Jun 30, 2008 as substantially equivalent to K992917 (Trudell Medical Int'L, 1999) and 2 other predicates after a 168-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Jun 30, 2008
- Review
- 168 days
- Class
- Class II
- Product code
- NVP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K962822 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962822 | Optichamber | Healthscan Products, Inc. | 1996 | — |
| −1 | K042546 | Funhaler, Model FH 101 | Infamed, Ltd. | 2005 | — |
| 0 (this device) | K080100 | Watchhaler | Activaero America, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2007 | 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 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
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K992917 | Aerochamber Plus Valved Holding ChamberSummary page 1…ebulizer (Direct Patient Interface) CAF - 868.5630 Predicate Devices: Trudell AeroChainber Plus Valved Holding Chamber K992917 Trudell AeroCharmber Plus aVHC with Flow-Vu IFI K070674 InfaMed Funhaler K0… | 1999 |
| * | K070674 | Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-VU Inspiratory Flow…Summary page 1…868.5630 Predicate Devices: Trudell AeroChainber Plus Valved Holding Chamber K992917 Trudell AeroCharmber Plus aVHC with Flow-Vu IFI K070674 InfaMed Funhaler K042546 IDevice Description The Watchhaler is a spacer primarily used in the pediat… | 2007 |
| * | K042546 | Funhaler, Model FH 101Summary page 1…ainber Plus Valved Holding Chamber K992917 Trudell AeroCharmber Plus aVHC with Flow-Vu IFI K070674 InfaMed Funhaler K042546 IDevice Description The Watchhaler is a spacer primarily used in the pediatric population for the inhalation of approved MDIs f… | 2005 |
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 12 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K992917.
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. 2008, 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 Watchhaler is a holding chamber intended to administer aerosolized medication with a Metered Dose Inhaler. For pediatric patients (3 years and older). The environment of use includes home care, nursing homes, sub-acute institutions, and hospitals
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080100 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080100: Watchhaler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080100
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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