FDA product code KEY: Stainer, Tissue, Automated

KEY is the FDA product code for stainer, tissue, automated. It is a Class I device, regulated under 21 CFR 864.3800 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under KEY. The average 510(k) review took 23 days (median 23). FDA has posted 5 recalls for KEY devices.

Classification

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

Top KEY applicants

Most recent KEY clearances

Recalls for KEY devices

5 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-01-23.

Frequently asked questions

What is FDA product code KEY?

KEY is the FDA product code for stainer, tissue, automated. It is a Class I device, regulated under 21 CFR 864.3800 and reviewed by the Pathology panel.

What device class is KEY?

Class I, regulation 21 CFR 864.3800. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 23 days from receipt to decision (median 23).

Which companies have the most KEY clearances?

Honeywell, Inc. (1).

Have KEY devices been recalled?

Yes: 5 product recalls across 5 recall events; the most recent began 2009-01-23.

Next steps

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