FDA product code FKX: System, Peritoneal, Automatic Delivery
FKX is the FDA product code for system, peritoneal, automatic delivery. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 83 510(k) submissions under FKX, 6 in the last five years, from 35 different applicants. The average 510(k) review took 106 days (median 81); 210 days on average over the last three years. FDA has posted 51 recalls for FKX devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Peritoneal, Automatic Delivery |
| Device class | Class II |
| Regulation | 21 CFR 876.5630 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for FKX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 102 |
| 2018 | 2 | 87 |
| 2020 | 1 | 135 |
| 2022 | 4 | 195 |
| 2025 | 2 | 210 |
Compare with all 510(k) review times · Search every FKX clearance
Top FKX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Medical Products, Inc. | 11 | 1983-06-02 |
| Travenol Laboratories, S.A. | 8 | 1987-09-30 |
| Fresenius Medical Care Renal Therapies Group, LLC | 6 | 2022-10-31 |
| Baxter Healthcare Corp | 6 | 2011-03-30 |
| Abbott Laboratories | 6 | 1989-11-28 |
30 more applicants have FKX clearances. See the full list in Caduvo.
Most recent FKX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250523 | Simergent, LLC | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) | 2025-10-02 | 223 |
| K243371 | Byonyks Pvt, Ltd. | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 | 2025-05-16 | 198 |
| K220935 | Iren-Medical, Ltd. | Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App | 2022-12-29 | 273 |
| K222318 | Fresenius Medical Care Renal Therapies Group, LLC | Fresenius Liberty Select Cycler | 2022-10-31 | 90 |
| K212522 | Fresenius Medical Care Renal Therapies Group, LLC | Lilliput APD System | 2022-04-15 | 247 |
Recalls for FKX devices
51 product recalls in 41 recall events; 5 initiated in the last five years and 4 still open. Most recent: 2025-08-28.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 5 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 3 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code FKX?
FKX is the FDA product code for system, peritoneal, automatic delivery. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel.
What device class is FKX?
Class II, regulation 21 CFR 876.5630. Typical premarket route: 510(k).
How long does a 510(k) take for product code FKX?
Across 83 cleared submissions the average was 106 days from receipt to decision (median 81).
Which companies have the most FKX clearances?
American Medical Products, Inc. (11); Travenol Laboratories, S.A. (8); Fresenius Medical Care Renal Therapies Group, LLC (6); Baxter Healthcare Corp (6); Abbott Laboratories (6).
Have FKX devices been recalled?
Yes: 51 product recalls across 41 recall events; the most recent began 2025-08-28.
Next steps
- Run an FDA pathway report with predicate devices for product code FKX
- Run a recall and safety report across every FKX manufacturer
- Watch product code FKX 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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