FDA product code KIM: Device For Sealing Microsections

KIM is the FDA product code for device for sealing microsections. It is a Class I device, regulated under 21 CFR 864.3400 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under KIM. The average 510(k) review took 61 days (median 61). FDA has posted 1 recall for KIM devices.

Classification

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

Top KIM applicants

Most recent KIM clearances

Recalls for KIM devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-09-04.

Frequently asked questions

What is FDA product code KIM?

KIM is the FDA product code for device for sealing microsections. It is a Class I device, regulated under 21 CFR 864.3400 and reviewed by the Pathology panel.

What device class is KIM?

Class I, regulation 21 CFR 864.3400. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 61 days from receipt to decision (median 61).

Which companies have the most KIM clearances?

Shandon, Inc. (1).

Have KIM devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2018-09-04.

Next steps

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