Atlas FDA

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.
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RecordFirmDate
UltraEzAir® (UEA1A) (K240114)Dualams, Inc., Dba Airkor2024-10-16
Medicant Mucosal Atomizer (K172956)Medica Holdings, LLC2018-04-06
MADgic Laryngo-Tracheal Mucosal Atomization Device (K153470)Teleflex Medical2016-08-19
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 Laboratories1981-02-26
ANESTHESIA KIT (K760759)Sherwood Medical Industries1976-12-09
MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT (K760877)Sherwood Medical Industries1976-12-09

Track CCT automatically

Every clearance here is in the API, with alerts when new ones post.