FDA product code PTM: Syringe, Balloon Inflation, Exempt

PTM is the FDA product code for syringe, balloon inflation, exempt. It is a Class II device, regulated under 21 CFR 870.1650 and reviewed by the Cardiovascular panel. Devices under PTM reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 7 recalls for PTM devices, 6 initiated in the last five years.

Definition

This product code is the class II exempt counterpart of MAV, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

Classification

Recalls for PTM devices

7 product recalls in 4 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2025-12-04.

Frequently asked questions

What is FDA product code PTM?

PTM is the FDA product code for syringe, balloon inflation, exempt. It is a Class II device, regulated under 21 CFR 870.1650 and reviewed by the Cardiovascular panel.

What device class is PTM?

Class II, regulation 21 CFR 870.1650. Typical premarket route: 510(k) exempt.

Have PTM devices been recalled?

Yes: 7 product recalls across 4 recall events; the most recent began 2025-12-04.

Next steps

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