FDA product code KSP: Apparatus, Cell-Freezing And Reagents

KSP is the FDA product code for apparatus, cell-freezing and reagents. It is a Class I device, regulated under 21 CFR 864.9225 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under KSP. The average 510(k) review took 15 days (median 15).

Classification

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

Top KSP applicants

Most recent KSP clearances

Recalls for KSP devices

openFDA lists no recalls for product code KSP.

Frequently asked questions

What is FDA product code KSP?

KSP is the FDA product code for apparatus, cell-freezing and reagents. It is a Class I device, regulated under 21 CFR 864.9225 and reviewed by the Hematology panel.

What device class is KSP?

Class I, regulation 21 CFR 864.9225. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 15 days from receipt to decision (median 15).

Which companies have the most KSP clearances?

Cryodyne Technologies, Inc. (1).

Next steps

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

All Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times