FDA product code KZB: Automated Colony Counter

KZB is the FDA product code for automated colony counter. It is a Class I device, regulated under 21 CFR 866.2170 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under KZB. The average 510(k) review took 99 days (median 99). FDA has posted 2 recalls for KZB devices, 2 initiated in the last five years.

Classification

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

Top KZB applicants

Most recent KZB clearances

Recalls for KZB devices

2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-05-06.

Frequently asked questions

What is FDA product code KZB?

KZB is the FDA product code for automated colony counter. It is a Class I device, regulated under 21 CFR 866.2170 and reviewed by the Microbiology panel.

What device class is KZB?

Class I, regulation 21 CFR 866.2170. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 99 days from receipt to decision (median 99).

Which companies have the most KZB clearances?

Statlabs, Inc. (1).

Have KZB devices been recalled?

Yes: 2 product recalls across 2 recall events; the most recent began 2025-05-06.

Next steps

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