FDA product code LTF: Stimulator, Salivary System

LTF is the FDA product code for stimulator, salivary system. It is a Class II device, regulated under 21 CFR 872.5560 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under LTF. The average 510(k) review took 276 days (median 276). 1 PMA application cites this product code. FDA has posted 35 recalls for LTF devices.

Classification

510(k) clearances per year for LTF

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

Top LTF applicants

Most recent LTF clearances

Recalls for LTF devices

35 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-10-24.

Frequently asked questions

What is FDA product code LTF?

LTF is the FDA product code for stimulator, salivary system. It is a Class II device, regulated under 21 CFR 872.5560 and reviewed by the Dental panel.

What device class is LTF?

Class II, regulation 21 CFR 872.5560. Typical premarket route: 510(k).

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

Across 2 cleared submissions the average was 276 days from receipt to decision (median 276).

Which companies have the most LTF clearances?

Saliwell , Ltd. (2).

Have LTF devices been recalled?

Yes: 35 product recalls across 1 recall events; the most recent began 2017-10-24.

Next steps

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