FDA product code LNZ: Changer, Tube, Endotracheal

LNZ is the FDA product code for changer, tube, endotracheal. It is a Class II device, regulated under 21 CFR 868.5730 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under LNZ. The average 510(k) review took 29 days (median 29). 1 PMA application cites this product code. FDA has posted 3 recalls for LNZ devices, 2 initiated in the last five years.

Classification

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

Top LNZ applicants

Most recent LNZ clearances

Recalls for LNZ devices

3 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-02-12.

Frequently asked questions

What is FDA product code LNZ?

LNZ is the FDA product code for changer, tube, endotracheal. It is a Class II device, regulated under 21 CFR 868.5730 and reviewed by the Anesthesiology panel.

What device class is LNZ?

Class II, regulation 21 CFR 868.5730. Typical premarket route: 510(k).

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

Across 1 cleared submissions the average was 29 days from receipt to decision (median 29).

Which companies have the most LNZ clearances?

Instrumentation Industries, Inc. (1).

Have LNZ devices been recalled?

Yes: 3 product recalls across 2 recall events; the most recent began 2024-02-12.

Next steps

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