FDA product code KSN: Centrifuge, Cell-Washing, Automated For Immuno-Hematology

KSN is the FDA product code for centrifuge, cell-washing, automated for immuno-hematology. It is a Class II device, regulated under 21 CFR 864.9285 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under KSN. The average 510(k) review took 34 days (median 34).

Classification

Compare with all 510(k) review times · Search every KSN clearance

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Most recent KSN clearances

Recalls for KSN devices

openFDA lists no recalls for product code KSN.

Frequently asked questions

What is FDA product code KSN?

KSN is the FDA product code for centrifuge, cell-washing, automated for immuno-hematology. It is a Class II device, regulated under 21 CFR 864.9285 and reviewed by the Hematology panel.

What device class is KSN?

Class II, regulation 21 CFR 864.9285. Typical premarket route: 510(k).

How long does a 510(k) take for product code KSN?

Across 1 cleared submissions the average was 34 days from receipt to decision (median 34).

Which companies have the most KSN clearances?

Dade, Baxter Travenol Diagnostics, Inc. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code KSN
• Run a recall and safety report across every KSN manufacturer
• Watch product code KSN 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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