FDA product code LKN: Separator, Automated, Blood Cell And Plasma, Therapeutic
LKN is the FDA product code for separator, automated, blood cell and plasma, therapeutic. It is a Unclassified device, reviewed by the Gastroenterology and Urology panel. FDA has cleared 27 510(k) submissions under LKN, from 16 different applicants. The average 510(k) review took 152 days (median 113). 6 PMA applications cite this product code. FDA has posted 12 recalls for LKN devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Device class | Unclassified |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for LKN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 3 | 217 |
| 2019 | 2 | 94 |
Compare with all 510(k) review times · Search every LKN clearance
Top LKN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Terumobct, Inc. | 7 | 2019-02-05 |
| Fenwal, Inc. | 2 | 2014-06-10 |
| Caridianbct, Inc.. | 2 | 2012-01-20 |
| Fresenius Medical Care North America | 2 | 2006-09-05 |
| Fresenius USA, Inc. | 2 | 1996-07-31 |
11 more applicants have LKN clearances. See the full list in Caduvo.
Most recent LKN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192150 | Fresenius Kabi AG | AMICUS Separator System | 2019-11-13 | 96 |
| K183081 | Terumobct, Inc. | Spectra Optia Apheresis System | 2019-02-05 | 91 |
| K180615 | Fresenius Kabi USA,Llc | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter | 2018-12-04 | 271 |
| K181049 | Terumobct, Inc. | Spectra Optia Apheresis System | 2018-11-01 | 195 |
| K172590 | Terumobct, Inc. | Spectra Optia Apheresis System | 2018-03-02 | 185 |
Recalls for LKN devices
12 product recalls in 10 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-02-14.
| Year | Recalls |
|---|---|
| 2021 | 2 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code LKN?
LKN is the FDA product code for separator, automated, blood cell and plasma, therapeutic. It is a Unclassified device, reviewed by the Gastroenterology and Urology panel.
What device class is LKN?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LKN?
Across 27 cleared submissions the average was 152 days from receipt to decision (median 113).
Which companies have the most LKN clearances?
Terumobct, Inc. (7); Fenwal, Inc. (2); Caridianbct, Inc.. (2); Fresenius Medical Care North America (2); Fresenius USA, Inc. (2).
Have LKN devices been recalled?
Yes: 12 product recalls across 10 recall events; the most recent began 2023-02-14.
Next steps
- Run an FDA pathway report with predicate devices for product code LKN
- Run a recall and safety report across every LKN manufacturer
- Watch product code LKN 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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