KYX · Dispenser, Liquid Medication
General Hospital · 21 CFR 880.6430 · Class 1
Overview
| Product Code | KYX |
|---|---|
| Device Name | Dispenser, Liquid Medication |
| Regulation | 21 CFR 880.6430 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K143177 | KleenGel Dispenser | Kleengel, LLC | Sep 14, 2015 | SESE |
| K980109 | CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER | Sangstat Medical Corp. | Aug 18, 1998 | SESE |
| K954181 | CANYONS BI-DIRECTIONAL CHECK VALVE | Canyon Medical Products | Nov 29, 1995 | SESE |
| K830571 | BOTTLE ADAPTER | Burron Medical Products, Inc. | Mar 24, 1983 | SESE |
| K801008 | MULTI-AD FLUID DISPENSING PUMP MP-3000 | Burron Medical Products, Inc. | Jun 2, 1980 | SESE |
| K800437 | SYRINGE TIP CONNECTOR | Burron Medical Products, Inc. | Mar 12, 1980 | SESE |
| K800362 | FLUID DISPENSING SYSTEM | Pharmaseal Laboratories | Mar 12, 1980 | SESE |
| K792227 | MULTI-AD FLUID DISPENSING SYSTEM | National Patent Development Corp. | Dec 20, 1979 | SESE |
| K781364 | PINT BOTTLE WELL | Baxa Corp., Sub. of Cook Group, Inc. | Oct 17, 1978 | SESE |
| K771539 | STEPPER | Tridak | Oct 7, 1977 | SESE |
| K760517 | CUP, DISPOSABLE MEDICINE | Landmark Plastics | Nov 12, 1976 | SESE |
Top Applicants
- Burron Medical Products, Inc. — 3 clearances
- Baxa Corp., Sub. of Cook Group, Inc. — 1 clearance
- Canyon Medical Products — 1 clearance
- Kleengel, LLC — 1 clearance
- Landmark Plastics — 1 clearance
