FDA product code CCT: Applicator (Laryngo-Tracheal), Topical Anesthesia
CCT is the FDA product code for applicator (laryngo-tracheal), topical anesthesia. It is a Class II device, regulated under 21 CFR 868.5170 and reviewed by the Anesthesiology panel. FDA has cleared 10 510(k) submissions under CCT, 1 in the last five years, from 9 different applicants. The average 510(k) review took 171 days (median 140); 274 days on average over the last three years. FDA has posted 6 recalls for CCT devices.
Classification
| Field | Value |
|---|---|
| Device name | Applicator (Laryngo-Tracheal), Topical Anesthesia |
| Device class | Class II |
| Regulation | 21 CFR 868.5170 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CCT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 192 |
| 2024 | 1 | 274 |
Compare with all 510(k) review times · Search every CCT clearance
Top CCT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sherwood Medical Industries | 2 | 1976-12-09 |
| Dualams, Inc., Dba Airkor | 1 | 2024-10-16 |
| Medica Holdings, LLC | 1 | 2018-04-06 |
| Teleflex Medical | 1 | 2016-08-19 |
| N.M. Beale Co., Inc. | 1 | 2011-03-04 |
4 more applicants have CCT clearances. See the full list in Caduvo.
Most recent CCT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240114 | Dualams, Inc., Dba Airkor | UltraEzAir® (UEA1A) | 2024-10-16 | 274 |
| K172956 | Medica Holdings, LLC | Medicant Mucosal Atomizer | 2018-04-06 | 192 |
| K153470 | Teleflex Medical | MADgic Laryngo-Tracheal Mucosal Atomization Device | 2016-08-19 | 261 |
| K093584 | N.M. Beale Co., Inc. | EZ-MISTER | 2011-03-04 | 470 |
| K070596 | Sharn, Inc. | TOPICAL APPLICATOR | 2007-06-21 | 111 |
Recalls for CCT devices
6 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-03-19.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
Frequently asked questions
What is FDA product code CCT?
CCT is the FDA product code for applicator (laryngo-tracheal), topical anesthesia. It is a Class II device, regulated under 21 CFR 868.5170 and reviewed by the Anesthesiology panel.
What device class is CCT?
Class II, regulation 21 CFR 868.5170. Typical premarket route: 510(k).
How long does a 510(k) take for product code CCT?
Across 10 cleared submissions the average was 171 days from receipt to decision (median 140).
Which companies have the most CCT clearances?
Sherwood Medical Industries (2); Dualams, Inc., Dba Airkor (1); Medica Holdings, LLC (1); Teleflex Medical (1); N.M. Beale Co., Inc. (1).
Have CCT devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2018-03-19.
Next steps
- Run an FDA pathway report with predicate devices for product code CCT
- Run a recall and safety report across every CCT manufacturer
- Watch product code CCT 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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