FDA product code KSO: Centrifuge, Blood-Bank For In Vitro Diagnostic Use

KSO is the FDA product code for centrifuge, blood-bank for in vitro diagnostic use. It is a Class I device, regulated under 21 CFR 864.9275 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under KSO. The average 510(k) review took 9 days (median 9).

Classification

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

Top KSO applicants

Most recent KSO clearances

Recalls for KSO devices

openFDA lists no recalls for product code KSO.

Frequently asked questions

What is FDA product code KSO?

KSO is the FDA product code for centrifuge, blood-bank for in vitro diagnostic use. It is a Class I device, regulated under 21 CFR 864.9275 and reviewed by the Hematology panel.

What device class is KSO?

Class I, regulation 21 CFR 864.9275. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 9 days from receipt to decision (median 9).

Which companies have the most KSO clearances?

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

Next steps

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