# K121969: U-Right Compressor Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Feb 28, 2013 after 238 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K990435 (2000). 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)
- K990435: Bestneb Portable Aerosol Therapy Unit, AP-100100, Apex Medical Corp. (2000) Summary page 2.

## Most influential descendants
- K192633: GUS831 Compressor Nebulizer (2020), 0 descendants of its own

## Indications for use
U-RIGHT Compressor Nebulizer, model TD-7013/ TD-7012, is designed to provide a compressed air source to aerosolize physician-prescribed liquid medication when used in combination with the packaged Nebulizer kit, except for Pentamidine. The packaged Nebulizer kit is intended for single use by single patient. U-RIGHT Compressor Nebulizer, model TD-7013/ TD-7012, is intended for use with children, adolescents (2 years to 18 years old), and adult patients in the homecare settings.

Source page: https://510kreport.com/device/K121969
Methodology: https://510kreport.com/methodology