510(k) · Cleared
ClearedAerochamber Z-Stat Plus Valved Holding Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trudell Medical Intl. · NVP Holding Chambers, Direct Patient Interface
Cleared on Sep 21, 2005 after a 26-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Sep 21, 2005
- Review
- 26 days
- Class
- Class II
- Product code
- NVP
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK052332 Aerochamber Z-Stat Plus Valved Holding ChamberTrudell Medical Intl. · 2005
- Descendant · cites it directly · 0 of its ownK140062 FSC Anti-Static Valved Collapsible Holding ChamberFsc Laboratories, Inc. · 2014 · Recalled
- Descendant · cites it directly · 0 of its ownK110293 Optichamber Diamond Valved Holding ChamberRespironics New Jersey, Inc. · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK072418 Optichamber Advantage Anti-Static Valved Holding ChamberRespironics New Jersey, Inc. · 2007
Most influential descendants
Showing 3 of 3 · See all- K140062FSC Anti-Static Valved Collapsible Holding ChamberFsc Laboratories, Inc. · 2014 · cites it directly0descendants
- K110293Optichamber Diamond Valved Holding ChamberRespironics New Jersey, Inc. · 2011 · cites it directly0descendants
- 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) | K052332 | Aerochamber Z-Stat Plus Valved Holding Chamber | Trudell Medical Intl. | 2005 | — |
| +1 | K140062 | FSC Anti-Static Valved Collapsible Holding Chamber | Fsc Laboratories, Inc. | 2014 | 1 |
| +1 | K110293 | Optichamber Diamond Valved Holding Chamber | Respironics New Jersey, Inc. | 2011 | 1 |
| +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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
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, K140062 (Fsc Laboratories, Inc., 2014) has gone furthest, with 0 descendants of its own.
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.
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 AeroChamber Z-STAT Plus TM Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K052332 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052332: Aerochamber Z-Stat 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/K052332
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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