LRD
6 FDA 510(k) clearances · Product code
140 daysmedian time to decision
472 days90th percentile
6clearances measured
FDA profile
- Official device name
- Applicator, Ent Drug
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.5220
- Medical specialty
- Ear, Nose, Throat
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AROMAPATCH (K984345) | Envis, Inc. | 1999-03-19 |
| AMSCO STERILE RECOVERIES SURGICAL PACKS (K932522) | Amsco Sterile Recoveries, Inc. | 1994-09-09 |
| MISTASSIST (K942789) | The Merlin Corp. | 1994-08-12 |
| THE EXPANDACELL EAR PACK (K940133) | Denver Splint Co. | 1994-05-23 |
| SURGICAL TRAY (STERILE) (K925022) | Customed, Inc. | 1993-04-26 |
| AEROSOL DELIVERY SYSTEMS (K920842) | Hospitak, Inc. | 1992-05-15 |
Track LRD automatically
Every clearance here is in the API, with alerts when new ones post.