# CCQ: Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

- Device class: 1; regulation: 21 CFR 868.5640; FDA's rule: 510(k) exempt
- FDA decisions: 62
- Recalls: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1985: 9
- 1986: 3
- 1987: 8
- 1988: 2
- 1989: 4
- 1990: 4
- 1991: 2
- 1992: 1
- 1996: 3
- 1997: 2

## Most-cited predicates
- K870027: Hand Held Pheumatic Powered (Disposable) Nebulizer (1987), cited by 6
- K870332: Prefilled Respiratory Therapy Vials (1987), cited by 3
- K894555: Pari Inhalierboy Type 37.80 Double Insulated (1990), cited by 1
- K900576: Modified Aerochamber with Mask (1991), cited by 1
- K841988: Arm-a-Vial LV Sodium, Chloride Inhalat (1984), cited by 1
- K922033: Saline Solution- Sterile (1992), cited by 1
- K841989: Arm-a-Vial LV Sodium Chloride Inhalat (1984), cited by 1
- K823423: Nebulizer Chronolog & Interpreter (1982), cited by 1
- K900557: Modified Aerochamber M.V. Aerosol Holding Chamber (1991), cited by 1
- K960593: Smartmist Asthma Managment System, Smartmist, Model Number SM-100/Smartmist Spirometry Airway, Model Number SA-100 (1996), cited by 1

Source page: https://510kreport.com/product-code/CCQ
Data by year (CSV): https://510kreport.com/product-code/CCQ.csv