FDA product code KDJ: Set, Administration, For Peritoneal Dialysis, Disposable
KDJ is the FDA product code for set, administration, for peritoneal dialysis, disposable. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 113 510(k) submissions under KDJ, 3 in the last five years, from 32 different applicants. The average 510(k) review took 107 days (median 77); 156 days on average over the last three years. FDA has posted 61 recalls for KDJ devices, 45 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Set, Administration, For Peritoneal Dialysis, Disposable |
| 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 KDJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 3 | 116 |
| 2019 | 1 | 28 |
| 2022 | 1 | 86 |
| 2024 | 1 | 263 |
| 2025 | 1 | 50 |
Compare with all 510(k) review times · Search every KDJ clearance
Top KDJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| National Medical Care, Medical Products Div., Inc. | 30 | 1994-08-31 |
| Travenol Laboratories, S.A. | 12 | 1987-10-20 |
| Baxter Healthcare Corp | 11 | 2003-11-20 |
| Abbott Laboratories | 7 | 1994-03-28 |
| American Medical Products, Inc. | 7 | 1981-11-16 |
27 more applicants have KDJ clearances. See the full list in Caduvo.
Most recent KDJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250404 | Fresenius Medical Care Renal Therapies Group, LLC | staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch | 2025-04-03 | 50 |
| K231849 | Baxter Healthcare | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 | 2024-03-12 | 263 |
| K214016 | Baxter Healthcare Corporation | 15L Cycler Drainage Bag | 2022-03-18 | 86 |
| K192705 | Baxter Healthcare | MiniCap Extended Life PD Transfer Sets | 2019-10-25 | 28 |
| K173593 | Fresenius Medical Care Renal Therapies Group, LLC | staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch | 2018-05-21 | 181 |
Recalls for KDJ devices
61 product recalls in 17 recall events; 45 initiated in the last five years and 39 still open. Most recent: 2024-10-23.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 4 |
| 2022 | 17 |
| 2023 | 2 |
| 2024 | 26 |
Frequently asked questions
What is FDA product code KDJ?
KDJ is the FDA product code for set, administration, for peritoneal dialysis, disposable. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel.
What device class is KDJ?
Class II, regulation 21 CFR 876.5630. Typical premarket route: 510(k).
How long does a 510(k) take for product code KDJ?
Across 113 cleared submissions the average was 107 days from receipt to decision (median 77).
Which companies have the most KDJ clearances?
National Medical Care, Medical Products Div., Inc. (30); Travenol Laboratories, S.A. (12); Baxter Healthcare Corp (11); Abbott Laboratories (7); American Medical Products, Inc. (7).
Have KDJ devices been recalled?
Yes: 61 product recalls across 17 recall events; the most recent began 2024-10-23.
Next steps
- Run an FDA pathway report with predicate devices for product code KDJ
- Run a recall and safety report across every KDJ manufacturer
- Watch product code KDJ 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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