FKYClass II
Connector, Tubing, Dialysate
21 CFR 876.5820 / Gastroenterology, Urology
FKY is the FDA product code for Connector, Tubing, Dialysate, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- FKY
- Device name
- Connector, Tubing, Dialysate
- Regulation
- 21 CFR 876.5820
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code FKY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1983 | 1 |
| 1986 | 1 |
| 1999 | 1 |
Applicants with the most clearances
Product code FKY| Applicant | Clearances |
|---|---|
| Abbott Medical | 1 |
| Dayspring Medical, Inc. | 1 |
| Mercury Enterprises, Inc. | 1 |
| Quinton, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code FKY.
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