FDA product code FKQ: System, Dialysate Delivery, Central Multiple Patient
FKQ is the FDA product code for system, dialysate delivery, central multiple patient. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 61 510(k) submissions under FKQ, from 39 different applicants. The average 510(k) review took 81 days (median 54). FDA has posted 2 recalls for FKQ devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Dialysate Delivery, Central Multiple Patient |
| 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 FKQ clearance
Top FKQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hospal Medical Corp. | 7 | 1984-04-02 |
| Travenol Laboratories, S.A. | 5 | 1985-01-16 |
| National Medical Care, Medical Products Div., Inc. | 4 | 1989-07-24 |
| Renal Systems, Inc. | 4 | 1987-06-09 |
| Extracorporeal Medical Specialities, Inc. | 4 | 1983-06-08 |
34 more applicants have FKQ clearances. See the full list in Caduvo.
Most recent FKQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052764 | B. Braun Medizintechnologie GmbH | DIACAP ULTRA DIALYSIS FLUID FILTER | 2006-06-09 | 252 |
| K893612 | National Medical Care, Medical Products Div., Inc. | TWO TANK DISSOLUTION MODULE | 1989-07-24 | 75 |
| K874084 | National Medical Care, Medical Products Div., Inc. | MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM | 1988-04-27 | 203 |
| K873421 | Kawasumi Laboratories Co., Ltd. | KAWASUMI A.V. FISTULA SET | 1987-10-09 | 45 |
| K870889 | D.R.G. Scientific Industries | ACID FUCHSIN SOLUTIONS | 1987-07-08 | 125 |
Recalls for FKQ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-04-20.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code FKQ?
FKQ is the FDA product code for system, dialysate delivery, central multiple patient. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FKQ?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FKQ?
Across 61 cleared submissions the average was 81 days from receipt to decision (median 54).
Which companies have the most FKQ clearances?
Hospal Medical Corp. (7); Travenol Laboratories, S.A. (5); National Medical Care, Medical Products Div., Inc. (4); Renal Systems, Inc. (4); Extracorporeal Medical Specialities, Inc. (4).
Have FKQ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2021-04-20.
Next steps
- Run an FDA pathway report with predicate devices for product code FKQ
- Run a recall and safety report across every FKQ manufacturer
- Watch product code FKQ 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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