FDA product code FJK: Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
FJK is the FDA product code for set, tubing, blood, with and without anti-regurgitation valve. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 77 510(k) submissions under FJK, 5 in the last five years, from 51 different applicants. The average 510(k) review took 155 days (median 88); 150 days on average over the last three years. FDA has posted 36 recalls for FJK devices, 15 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve |
| 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 |
510(k) clearances per year for FJK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 373 |
| 2018 | 1 | 274 |
| 2021 | 3 | 283 |
| 2023 | 1 | 526 |
| 2024 | 1 | 29 |
| 2025 | 1 | 146 |
| 2026 | 2 | 274 |
Compare with all 510(k) review times · Search every FJK clearance
Top FJK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| National Medical Care, Medical Products Div., Inc. | 7 | 1996-11-01 |
| Extracorporeal Medical Specialities, Inc. | 6 | 1983-10-14 |
| Erika, Inc. | 5 | 1985-07-26 |
| Fresenius Medical Care North America | 4 | 2001-08-16 |
| Bain Medical Equipment (Guangzhou) Co., Ltd. | 3 | 2026-05-15 |
46 more applicants have FJK clearances. See the full list in Caduvo.
Most recent FJK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252423 | Bain Medical Equipment (Guangzhou) Co., Ltd. | NovaLine Tubing Set for Hemodialysis (BL 124) | 2026-05-15 | 287 |
| K251341 | Vital Healthcare Sdn. Bhd. | VITAL Tubing Sets for Hemodialysis | 2026-01-16 | 261 |
| K251442 | Ningbo Tianyi Medical Appliance Co., Ltd. | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | 2025-10-02 | 146 |
| K243607 | Diality, Inc. | Moda-flx Hemodialysis System Cartridge (102121-001 ) | 2024-12-20 | 29 |
| K213992 | Fresenius Medical Care Renal Therapies Group, LLC | CombiSet Hemodialysis Blood Tubing Set | 2023-05-31 | 526 |
Recalls for FJK devices
36 product recalls in 14 recall events; 15 initiated in the last five years and 22 still open. Most recent: 2026-07-29.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2020 | 11 |
| 2021 | 1 |
| 2024 | 7 |
| 2025 | 1 |
| 2026 | 7 |
Frequently asked questions
What is FDA product code FJK?
FJK is the FDA product code for set, tubing, blood, with and without anti-regurgitation valve. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FJK?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FJK?
Across 77 cleared submissions the average was 155 days from receipt to decision (median 88).
Which companies have the most FJK clearances?
National Medical Care, Medical Products Div., Inc. (7); Extracorporeal Medical Specialities, Inc. (6); Erika, Inc. (5); Fresenius Medical Care North America (4); Bain Medical Equipment (Guangzhou) Co., Ltd. (3).
Have FJK devices been recalled?
Yes: 36 product recalls across 14 recall events; the most recent began 2026-07-29.
Next steps
- Run an FDA pathway report with predicate devices for product code FJK
- Run a recall and safety report across every FJK manufacturer
- Watch product code FJK 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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