Dispenser, Liquid Medication
The Liquid Medication Dispenser is a device used to measure and dispense precise volumes of liquid medications to patients, facilitating accurate dosing in clinical, pharmacy, or home care environments. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, and is exempt from Good Manufacturing Practice (GMP) requirements. The product code is KYX, regulated under 21 CFR 880.6430, in the General Hospital medical specialty. This device is GMP exempt.
Research product code KYX in seconds
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Basic Information
- Product Code
- KYX
- Device Class
- FDA class 1
- Regulation Number
- 880.6430
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K143177 | KleenGel Dispenser | Sep 14, 2015 | Substantially Equivalent | Kleengel, LLC |
| K980109 | CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER | Aug 18, 1998 | Substantially Equivalent | Sangstat Medical Corp. |
| K954181 | CANYONS BI-DIRECTIONAL CHECK VALVE | Nov 29, 1995 | Substantially Equivalent | Canyon Medical Products |
| K830571 | BOTTLE ADAPTER | Mar 24, 1983 | Substantially Equivalent | Burron Medical Products, Inc. |
| K801008 | MULTI-AD FLUID DISPENSING PUMP MP-3000 | Jun 02, 1980 | Substantially Equivalent | Burron Medical Products, Inc. |
| K800437 | SYRINGE TIP CONNECTOR | Mar 12, 1980 | Substantially Equivalent | Burron Medical Products, Inc. |
| K800362 | FLUID DISPENSING SYSTEM | Mar 12, 1980 | Substantially Equivalent | Pharmaseal Laboratories |
| K792227 | MULTI-AD FLUID DISPENSING SYSTEM | Dec 20, 1979 | Substantially Equivalent | National Patent Development Corp. |
| K781364 | PINT BOTTLE WELL | Oct 17, 1978 | Substantially Equivalent | Baxa Corp., Sub. of Cook Group, Inc. |
| K771539 | STEPPER | Oct 07, 1977 | Substantially Equivalent | Tridak |
| K760517 | CUP, DISPOSABLE MEDICINE | Nov 12, 1976 | Substantially Equivalent | Landmark Plastics |
FEI Numbers
This FDA classification entry is associated with 275 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 276 registration numbers. Click on an entry to view related FDA registrations.