FDA product code KYX: Dispenser, Liquid Medication
KYX is the FDA product code for dispenser, liquid medication. It is a Class I device, regulated under 21 CFR 880.6430 and reviewed by the General Hospital panel. FDA has cleared 11 510(k) submissions under KYX, from 9 different applicants. The average 510(k) review took 88 days (median 57). FDA has posted 17 recalls for KYX devices, 12 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dispenser, Liquid Medication |
| Device class | Class I |
| Regulation | 21 CFR 880.6430 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KYX clearance
Top KYX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Burron Medical Products, Inc. | 3 | 1983-03-24 |
| Kleengel, LLC | 1 | 2015-09-14 |
| Sangstat Medical Corp. | 1 | 1998-08-18 |
| Canyon Medical Products | 1 | 1995-11-29 |
| Pharmaseal Laboratories | 1 | 1980-03-12 |
4 more applicants have KYX clearances. See the full list in Caduvo.
Most recent KYX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K143177 | Kleengel, LLC | KleenGel Dispenser | 2015-09-14 | 314 |
| K980109 | Sangstat Medical Corp. | CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER | 1998-08-18 | 218 |
| K954181 | Canyon Medical Products | CANYONS BI-DIRECTIONAL CHECK VALVE | 1995-11-29 | 84 |
| K830571 | Burron Medical Products, Inc. | BOTTLE ADAPTER | 1983-03-24 | 29 |
| K801008 | Burron Medical Products, Inc. | MULTI-AD FLUID DISPENSING PUMP MP-3000 | 1980-06-02 | 35 |
Recalls for KYX devices
17 product recalls in 9 recall events; 12 initiated in the last five years and 11 still open. Most recent: 2024-03-04.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2022 | 8 |
| 2023 | 1 |
| 2024 | 3 |
Frequently asked questions
What is FDA product code KYX?
KYX is the FDA product code for dispenser, liquid medication. It is a Class I device, regulated under 21 CFR 880.6430 and reviewed by the General Hospital panel.
What device class is KYX?
Class I, regulation 21 CFR 880.6430. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KYX?
Across 11 cleared submissions the average was 88 days from receipt to decision (median 57).
Which companies have the most KYX clearances?
Burron Medical Products, Inc. (3); Kleengel, LLC (1); Sangstat Medical Corp. (1); Canyon Medical Products (1); Pharmaseal Laboratories (1).
Have KYX devices been recalled?
Yes: 17 product recalls across 9 recall events; the most recent began 2024-03-04.
Next steps
- Run an FDA pathway report with predicate devices for product code KYX
- Run a recall and safety report across every KYX manufacturer
- Watch product code KYX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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