FDA product code KYW: Container, Liquid Medication, Graduated
KYW is the FDA product code for container, liquid medication, graduated. It is a Class I device, regulated under 21 CFR 880.6430 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under KYW, from 2 different applicants. The average 510(k) review took 24 days (median 24). FDA has posted 13 recalls for KYW devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Container, Liquid Medication, Graduated |
| 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 KYW clearance
Top KYW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cutter Laboratories, Inc. | 1 | 1980-02-26 |
| General Clinical Plastics Corp. | 1 | 1979-08-03 |
Most recent KYW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K800213 | Cutter Laboratories, Inc. | PHARMACY ADDITIVE SYRINGE SET | 1980-02-26 | 25 |
| K791345 | General Clinical Plastics Corp. | MEDICINE CUP | 1979-08-03 | 22 |
Recalls for KYW devices
13 product recalls in 5 recall events; 10 initiated in the last five years and 10 still open. Most recent: 2025-10-14.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2022 | 8 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code KYW?
KYW is the FDA product code for container, liquid medication, graduated. It is a Class I device, regulated under 21 CFR 880.6430 and reviewed by the General Hospital panel.
What device class is KYW?
Class I, regulation 21 CFR 880.6430. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KYW?
Across 2 cleared submissions the average was 24 days from receipt to decision (median 24).
Which companies have the most KYW clearances?
Cutter Laboratories, Inc. (1); General Clinical Plastics Corp. (1).
Have KYW devices been recalled?
Yes: 13 product recalls across 5 recall events; the most recent began 2025-10-14.
Next steps
- Run an FDA pathway report with predicate devices for product code KYW
- Run a recall and safety report across every KYW manufacturer
- Watch product code KYW 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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