# K091272: Besmed Jet Nebulizer Bottle Set

- Pathway: 510(k) (Traditional)
- Applicant: Besmed Health Business Corp
- Decided: Nov 10, 2009 after 194 days
- Product code: CAF (Nebulizer (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: 2 generations back to K883964 (1988). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052811: Hsiner Jet Nebulizer, Model HS-31100, Hsiner Co., Ltd. (2005) Summary page 1.

## Most influential descendants
- K212395: Nebulizer (2022), 0 descendants of its own

## Recalls of this device
- Aug 29, 2018 · Class II · Z-1058-2019: The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for the device to overheat and the mouthpiece can pop off.

## Indications for use
The BESMED Jet Nebulizer Bottle Set is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

Source page: https://510kreport.com/device/K091272
Methodology: https://510kreport.com/methodology