Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CCT — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
169 daysmedian FDA review time
470 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240114 | UltraEzAir® (UEA1A) | Dualams, Inc., Dba Airkor | 2024-10-16 | 274 | 0 |
| K172956 | Medicant Mucosal Atomizer | Medica Holdings, LLC | 2018-04-06 | 192 | 0 |
| K153470 | MADgic Laryngo-Tracheal Mucosal Atomization Device | Teleflex Medical | 2016-08-19 | 261 | 3 |
| K093584 | EZ-MISTER | N.M. Beale Co., Inc. | 2011-03-04 | 470 | 0 |
| K070596 | TOPICAL APPLICATOR | Sharn, Inc. | 2007-06-21 | 111 | 3 |
| K002255 | LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) | Wolfe Tory Medical, Inc. | 2000-09-18 | 55 | 0 |
| K894755 | ASTRA DISPOSABLE SPRAY CANNULA | Astra Pharmaceutical Products, Inc. | 1990-01-12 | 169 | 0 |
| K810059 | ENDO-MED TUBE FOR ENDOTRACHEAL MED | Ackrad Laboratories | 1981-02-26 | 44 | 0 |
| K760759 | ANESTHESIA KIT | Sherwood Medical Industries | 1976-12-09 | 66 | 0 |
| K760877 | MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT | Sherwood Medical Industries | 1976-12-09 | 66 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda