Product code KYX
- Device name
- Dispenser, Liquid Medication
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.6430
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143177 | KleenGel Dispenser | Kleengel, LLC | 2015-09-14 |
| K980109 | CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER | Sangstat Medical Corp. | 1998-08-18 |
| K954181 | CANYONS BI-DIRECTIONAL CHECK VALVE | Canyon Medical Products | 1995-11-29 |
| K830571 | BOTTLE ADAPTER | Burron Medical Products, Inc. | 1983-03-24 |
| K801008 | MULTI-AD FLUID DISPENSING PUMP MP-3000 | Burron Medical Products, Inc. | 1980-06-02 |
| K800362 | FLUID DISPENSING SYSTEM | Pharmaseal Laboratories | 1980-03-12 |
| K800437 | SYRINGE TIP CONNECTOR | Burron Medical Products, Inc. | 1980-03-12 |
| K792227 | MULTI-AD FLUID DISPENSING SYSTEM | National Patent Development Corp. | 1979-12-20 |
| K781364 | PINT BOTTLE WELL | Baxa Corp., Sub. of Cook Group, Inc. | 1978-10-17 |
| K771539 | STEPPER | Tridak | 1977-10-07 |
| K760517 | CUP, DISPOSABLE MEDICINE | Landmark Plastics | 1976-11-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B21257701001 | Oral Tamper Evident Cap | INTERNATIONAL MEDICAL INDUSTRIES INC. | 2022-12-22 |
| 05060590882931 | Enteral | GBUK GROUP LIMITED | 2022-11-01 |
| 05060590882917 | Enteral | GBUK GROUP LIMITED | 2022-11-01 |
| 05060590881804 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060498307567 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060498307598 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060590881835 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060590881866 | Enteral | GBUK GROUP LIMITED | 2022-10-28 |
| 05060460843475 | CareTip | GBUK GROUP LIMITED | 2022-10-20 |
| 05060590881255 | CareTip | GBUK GROUP LIMITED | 2022-10-20 |
| 05060460845790 | CareTip | GBUK GROUP LIMITED | 2022-10-20 |
| 05060460843444 | CareTip | GBUK GROUP LIMITED | 2022-10-20 |
| 05060460843413 | CareTip | GBUK GROUP LIMITED | 2022-10-20 |
| 05060460848340 | CareTip | GBUK GROUP LIMITED | 2022-10-20 |
| 00850801006967 | Enteral | GBUK GROUP LIMITED | 2022-10-20 |
| 05060460848326 | CareTip | GBUK GROUP LIMITED | 2022-10-20 |
| 05060460848302 | CareTip | GBUK GROUP LIMITED | 2022-10-20 |
| 05060460848289 | CareTip | GBUK GROUP LIMITED | 2022-10-20 |
| 05060460848166 | Enteral | GBUK GROUP LIMITED | 2022-10-19 |
| 05060460848227 | Enteral | GBUK GROUP LIMITED | 2022-10-19 |
| 05060460848197 | Enteral | GBUK GROUP LIMITED | 2022-10-19 |
| 05060460848135 | Enteral | GBUK GROUP LIMITED | 2022-10-19 |
| 05060460848104 | Enteral | GBUK GROUP LIMITED | 2022-10-19 |
| 05060460848074 | Enteral | GBUK GROUP LIMITED | 2022-10-19 |
| 05060460845646 | Enteral | GBUK GROUP LIMITED | 2022-10-19 |
| 05060460845615 | Enteral | GBUK GROUP LIMITED | 2022-10-19 |
| 05060460845585 | Enteral | GBUK GROUP LIMITED | 2022-10-19 |
| 05060460845554 | Enteral | GBUK GROUP LIMITED | 2022-10-19 |
| B21273211 | Oral Tamper Evident Cap | INTERNATIONAL MEDICAL INDUSTRIES INC. | 2016-10-14 |
| B2125770IMI1 | Oral Tamper Evident Cap | INTERNATIONAL MEDICAL INDUSTRIES INC. | 2016-09-23 |