KYX
11 FDA 510(k) clearances · Product code
57 daysmedian time to decision
218 days90th percentile
11clearances measured
FDA profile
- Official device name
- Dispenser, Liquid Medication
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6430
- Medical specialty
- General Hospital
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2017: 17 · 2018: 17 · 2019: 17 · 2020: 33 · 2023: 31 · 2024: 20
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 |
|---|---|---|
| KleenGel Dispenser (K143177) | Kleengel, LLC | 2015-09-14 |
| CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER (K980109) | Sangstat Medical Corp. | 1998-08-18 |
| CANYONS BI-DIRECTIONAL CHECK VALVE (K954181) | Canyon Medical Products | 1995-11-29 |
| BOTTLE ADAPTER (K830571) | Burron Medical Products, Inc. | 1983-03-24 |
| MULTI-AD FLUID DISPENSING PUMP MP-3000 (K801008) | Burron Medical Products, Inc. | 1980-06-02 |
| FLUID DISPENSING SYSTEM (K800362) | Pharmaseal Laboratories | 1980-03-12 |
| SYRINGE TIP CONNECTOR (K800437) | Burron Medical Products, Inc. | 1980-03-12 |
| MULTI-AD FLUID DISPENSING SYSTEM (K792227) | National Patent Development Corp. | 1979-12-20 |
| PINT BOTTLE WELL (K781364) | Baxa Corp., Sub. of Cook Group, Inc. | 1978-10-17 |
| STEPPER (K771539) | Tridak | 1977-10-07 |
| CUP, DISPOSABLE MEDICINE (K760517) | Landmark Plastics | 1976-11-12 |
Track KYX automatically
Every clearance here is in the API, with alerts when new ones post.