FDA product code FKR: Subsystem, Proportioning
FKR is the FDA product code for subsystem, proportioning. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 12 510(k) submissions under FKR, from 8 different applicants. The average 510(k) review took 82 days (median 68). FDA has posted 10 recalls for FKR devices.
Classification
| Field | Value |
|---|---|
| Device name | Subsystem, Proportioning |
| 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 FKR clearance
Top FKR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nxstage Medical, Inc. | 5 | 2014-05-15 |
| Sartorius Filters, Inc. | 1 | 1985-06-04 |
| Travenol Laboratories, S.A. | 1 | 1985-03-20 |
| Trimedyne, Inc. | 1 | 1981-06-16 |
| Gambro, Inc. | 1 | 1981-02-25 |
3 more applicants have FKR clearances. See the full list in Caduvo.
Most recent FKR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140571 | Nxstage Medical, Inc. | NXSTAGE PUREFLOW SL | 2014-05-15 | 70 |
| K111174 | Nxstage Medical, Inc. | NXSTAGE PUREFLOW SL | 2011-09-19 | 145 |
| K080919 | Nxstage Medical, Inc. | NXSTAGE PUREFLOW SL | 2008-10-15 | 197 |
| K060296 | Nxstage Medical, Inc. | NXSTAGE DIALYSATE PREPARATION MODULE | 2006-03-31 | 53 |
| K043436 | Nxstage Medical, Inc. | NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 | 2005-03-17 | 94 |
Recalls for FKR devices
10 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-01-29.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code FKR?
FKR is the FDA product code for subsystem, proportioning. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FKR?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FKR?
Across 12 cleared submissions the average was 82 days from receipt to decision (median 68).
Which companies have the most FKR clearances?
Nxstage Medical, Inc. (5); Sartorius Filters, Inc. (1); Travenol Laboratories, S.A. (1); Trimedyne, Inc. (1); Gambro, Inc. (1).
Have FKR devices been recalled?
Yes: 10 product recalls across 3 recall events; the most recent began 2018-01-29.
Next steps
- Run an FDA pathway report with predicate devices for product code FKR
- Run a recall and safety report across every FKR manufacturer
- Watch product code FKR 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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