CCT
10 FDA 510(k) clearances · Product code
169 daysmedian time to decision
470 days90th percentile
10clearances measured
FDA profile
- Official device name
- Applicator (Laryngo-Tracheal), Topical Anesthesia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5170
- Medical specialty
- Anesthesiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2010: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| UltraEzAir® (UEA1A) (K240114) | Dualams, Inc., Dba Airkor | 2024-10-16 |
| Medicant Mucosal Atomizer (K172956) | Medica Holdings, LLC | 2018-04-06 |
| MADgic Laryngo-Tracheal Mucosal Atomization Device (K153470) | Teleflex Medical | 2016-08-19 |
| EZ-MISTER (K093584) | N.M. Beale Co., Inc. | 2011-03-04 |
| TOPICAL APPLICATOR (K070596) | Sharn, Inc. | 2007-06-21 |
| LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) (K002255) | Wolfe Tory Medical, Inc. | 2000-09-18 |
| ASTRA DISPOSABLE SPRAY CANNULA (K894755) | Astra Pharmaceutical Products, Inc. | 1990-01-12 |
| ENDO-MED TUBE FOR ENDOTRACHEAL MED (K810059) | Ackrad Laboratories | 1981-02-26 |
| ANESTHESIA KIT (K760759) | Sherwood Medical Industries | 1976-12-09 |
| MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT (K760877) | Sherwood Medical Industries | 1976-12-09 |
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Every clearance here is in the API, with alerts when new ones post.