FDA product code KDN: System, Perfusion, Kidney
KDN is the FDA product code for system, perfusion, kidney. It is a Class II device, regulated under 21 CFR 876.5880 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 44 510(k) submissions under KDN, 13 in the last five years, from 22 different applicants. The average 510(k) review took 172 days (median 156); 166 days on average over the last three years. FDA has posted 5 recalls for KDN devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Perfusion, Kidney |
| Device class | Class II |
| Regulation | 21 CFR 876.5880 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KDN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 292 |
| 2019 | 2 | 182 |
| 2020 | 2 | 86 |
| 2021 | 3 | 251 |
| 2022 | 1 | 262 |
| 2023 | 2 | 238 |
| 2024 | 2 | 285 |
| 2025 | 5 | 143 |
| 2026 | 3 | 69 |
Compare with all 510(k) review times · Search every KDN clearance
Top KDN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Preservation Solutions, Inc. | 5 | 2015-09-18 |
| Xvivo Perfusion AB | 4 | 2026-07-23 |
| Paragonix Technologies | 4 | 2024-10-23 |
| Traferox Technologies, Inc. | 3 | 2026-06-01 |
| Paragonix Technologies, Inc. | 3 | 2026-01-30 |
17 more applicants have KDN clearances. See the full list in Caduvo.
Most recent KDN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261644 | Xvivo Perfusion AB | Perfadex Plus | 2026-07-23 | 66 |
| K260456 | Traferox Technologies, Inc. | VI°Port Liver Preservation System | 2026-06-01 | 110 |
| K254305 | Paragonix Technologies, Inc. | BAROguard Donor Lung Preservation System | 2026-01-30 | 30 |
| K243618 | Bridge TO Life | EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) | 2025-06-17 | 207 |
| K243870 | Traferox Technologies, Inc. | X°Port Lung Preservation System; X°Port Lung Preservation Solution | 2025-05-01 | 135 |
Recalls for KDN devices
5 product recalls in 5 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2025-06-12.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code KDN?
KDN is the FDA product code for system, perfusion, kidney. It is a Class II device, regulated under 21 CFR 876.5880 and reviewed by the Gastroenterology and Urology panel.
What device class is KDN?
Class II, regulation 21 CFR 876.5880. Typical premarket route: 510(k).
How long does a 510(k) take for product code KDN?
Across 44 cleared submissions the average was 172 days from receipt to decision (median 156).
Which companies have the most KDN clearances?
Preservation Solutions, Inc. (5); Xvivo Perfusion AB (4); Paragonix Technologies (4); Traferox Technologies, Inc. (3); Paragonix Technologies, Inc. (3).
Have KDN devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2025-06-12.
Next steps
- Run an FDA pathway report with predicate devices for product code KDN
- Run a recall and safety report across every KDN manufacturer
- Watch product code KDN 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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