# K181649: AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)

- Pathway: 510(k) (Traditional)
- Applicant: Trudell Medical International
- Decided: Jan 11, 2019 after 203 days
- Product code: NVP (Holding Chambers, Direct Patient Interface)
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K112010 (2012). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112010: Aerochamber Plus Flow-VU Anti-Static Valved Holding Chamber (VHC), Trudell Medical Intl. (2012) Summary page 4.

## Most influential descendants
- K242667: AeroChamber2go Anti-Static Valved Holding Chamber (2025), 0 descendants of its own

## Recalls of this device
- Mar 16, 2021 · Class II · Z-1932-2021: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K181649
Methodology: https://510kreport.com/methodology