510(k) · Cleared
ClearedAerochamber Plus Anti-Static Valved Holding Chamber with Flow-VU Inspiratory Flow Indicator
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 Apr 11, 2007 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Apr 11, 2007
- Review
- 30 days
- Class
- Class II
- Product code
- NVP
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 5 citing it directly.
- This deviceK070674 Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-VU…Trudell Medical Intl. · 2007
- Descendant · cites it directly · 1 of its ownK091862 Nessi SpacerPharmacaribe · 2009
- Descendant · cites it directly · 0 of its ownK122252 Space Chamber Plus Compact Space Chamber PlusMedical Developments International · 2013
- Descendant · cites it directly · 0 of its ownK101348 Agachamber SpacerAga Plastic Ind. Com. Ltda. · 2011
- Descendant · cites it directly · 0 of its ownK101136 Fisio Chamber SpaceKoo (Shanghai) Industries Co., Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK101532 Nessi Otc SpacerPharmacaribe · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K091862Nessi SpacerPharmacaribe · 2009 · cites it directly1descendant
- K122252Space Chamber Plus Compact Space Chamber PlusMedical Developments International · 2013 · cites it directly0descendants
- K101348Agachamber SpacerAga Plastic Ind. Com. Ltda. · 2011 · cites it directly0descendants
- K101136Fisio Chamber SpaceKoo (Shanghai) Industries Co., Ltd. · 2011 · cites it directly0descendants
- K101532Nessi Otc SpacerPharmacaribe · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070674 | Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-VU Inspiratory… | Trudell Medical Intl. | 2007 | — |
| +1 | K091862 | Nessi Spacer | Pharmacaribe | 2009 | — |
| +1 | K122252 | Space Chamber Plus Compact Space Chamber Plus | Medical Developments International | 2013 | — |
| +1 | K101348 | Agachamber Spacer | Aga Plastic Ind. Com. Ltda. | 2011 | — |
| +1 | K101136 | Fisio Chamber Space | Koo (Shanghai) Industries Co., Ltd. | 2011 | — |
| +2 | K101532 | Nessi Otc Spacer | Pharmacaribe | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 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? (6)
5 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, K091862 (Pharmacaribe, 2009) has gone furthest, with 1 descendant 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. 2007, 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 AeroChamber Plus®aVHC with Flow-Vu® IFI 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/K070674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070674: Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-VU Inspiratory Flow Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070674
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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