FDA product code FKY: Connector, Tubing, Dialysate
FKY is the FDA product code for connector, tubing, dialysate. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under FKY, from 4 different applicants. The average 510(k) review took 62 days (median 72).
Classification
| Field | Value |
|---|---|
| Device name | Connector, Tubing, Dialysate |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every FKY clearance
Top FKY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dayspring Medical, Inc. | 1 | 1999-06-09 |
| Mercury Enterprises, Inc. | 1 | 1986-08-11 |
| Abbott Laboratories | 1 | 1983-03-11 |
| Quinton, Inc. | 1 | 1977-10-18 |
Most recent FKY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K991003 | Dayspring Medical, Inc. | PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI | 1999-06-09 | 76 |
| K862722 | Mercury Enterprises, Inc. | TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE | 1986-08-11 | 25 |
| K830002 | Abbott Laboratories | CAPD COLOR-GUARD SYSTEM PREPKIT | 1983-03-11 | 67 |
| K771428 | Quinton, Inc. | TENCKHOFF PERITONEAL TUBING ADAPT. | 1977-10-18 | 78 |
Recalls for FKY devices
openFDA lists no recalls for product code FKY.
Frequently asked questions
What is FDA product code FKY?
FKY is the FDA product code for connector, tubing, dialysate. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FKY?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FKY?
Across 4 cleared submissions the average was 62 days from receipt to decision (median 72).
Which companies have the most FKY clearances?
Dayspring Medical, Inc. (1); Mercury Enterprises, Inc. (1); Abbott Laboratories (1); Quinton, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FKY
- Run a recall and safety report across every FKY manufacturer
- Watch product code FKY 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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