510(k) · Cleared
Recalled · Class II · 2021AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trudell Medical International · NVP Holding Chambers, Direct Patient Interface
Cleared on Jan 11, 2019 as substantially equivalent to K112010 (Trudell Medical Intl., 2012) after a 203-day review. Its family tree reaches back 1 generation to 2012. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 11, 2019
- Review
- 203 days
- Class
- Class II
- Product code
- NVP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K112010 (2012). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK112010 Aerochamber Plus Flow-VU Anti-Static Valved Holding Chamber (VHC)Trudell Medical Intl. · 2012
- This deviceK181649 AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)Trudell Medical International · 2019
- Descendant · cites it directly · 0 of its ownK242667 AeroChamber2go Anti-Static Valved Holding ChamberTrudell Medical International · 2025
Most influential descendants
Showing 1 of 1 · See all- K242667AeroChamber2go Anti-Static Valved Holding ChamberTrudell Medical International · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K112010 | Aerochamber Plus Flow-VU Anti-Static Valved Holding Chamber (VHC) | Trudell Medical Intl. | 2012 | — |
| 0 (this device) | K181649 | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) | Trudell Medical International | 2019 | — |
| +1 | K242667 | AeroChamber2go Anti-Static Valved Holding Chamber | Trudell Medical International | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K112010 | Aerochamber Plus Flow-VU Anti-Static Valved Holding Chamber (VHC)Summary page 4…Regulatory Class: II Product Code: NVP 3. Predicate Device Trade Name: AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber 510(k) Number: K112010 510(k) Owner: Trudell Medical International The predicate device has not been subject to a recall. 4. Device Description… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242667 | AeroChamber2go Anti-Static Valved Holding Chamber | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2021 | Class II | Z-1932-2021 | Environmental control | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K242667 (Trudell Medical International, 2025) 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. 2019, 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* Flow-Vu* Anti-Static Valved Holding Chamber is intended to be used by adult and pediatric patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers and Soft Mist Inhalers. The intended environments for use include the home, hospitals and clinics. It is a single patient, multiple use device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181649: AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181649
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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