FDA product code CCQ: Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
CCQ is the FDA product code for nebulizer, medicinal, non-ventilatory (atomizer). It is a Class I device, regulated under 21 CFR 868.5640 and reviewed by the Anesthesiology panel. FDA has cleared 62 510(k) submissions under CCQ, from 46 different applicants. The average 510(k) review took 78 days (median 60). FDA has posted 9 recalls for CCQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) |
| Device class | Class I |
| Regulation | 21 CFR 868.5640 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CCQ clearance
Top CCQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Armour Pharmaceutical Co. | 5 | 1984-07-27 |
| Monaghan Medical Corp. | 3 | 1991-05-13 |
| Vortran Medical Technology 1, Inc. | 3 | 1987-10-09 |
| Syva Co. | 2 | 1990-01-17 |
| Devilbiss Health Care, Inc. | 2 | 1989-10-13 |
41 more applicants have CCQ clearances. See the full list in Caduvo.
Most recent CCQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972397 | Intertex Research, Inc. | EZ SPRAY | 1997-09-23 | 89 |
| K964956 | Airpharma, LLC | E-Z SPACER MASK (SMALL) | 1997-04-23 | 133 |
| K961894 | Mdi Tutor, Inc. | MDI TUTOR | 1996-08-14 | 90 |
| K961455 | Diemolding Corp. | MEDSHIELD/AEROCHAMBER | 1996-07-25 | 100 |
| K960593 | Aradigm Corp. | SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100 | 1996-05-10 | 88 |
Recalls for CCQ devices
9 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-10-27.
Frequently asked questions
What is FDA product code CCQ?
CCQ is the FDA product code for nebulizer, medicinal, non-ventilatory (atomizer). It is a Class I device, regulated under 21 CFR 868.5640 and reviewed by the Anesthesiology panel.
What device class is CCQ?
Class I, regulation 21 CFR 868.5640. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CCQ?
Across 62 cleared submissions the average was 78 days from receipt to decision (median 60).
Which companies have the most CCQ clearances?
Armour Pharmaceutical Co. (5); Monaghan Medical Corp. (3); Vortran Medical Technology 1, Inc. (3); Syva Co. (2); Devilbiss Health Care, Inc. (2).
Have CCQ devices been recalled?
Yes: 9 product recalls across 3 recall events; the most recent began 2016-10-27.
Next steps
- Run an FDA pathway report with predicate devices for product code CCQ
- Run a recall and safety report across every CCQ manufacturer
- Watch product code CCQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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