FDA product code MDS: Sensor, Glucose, Invasive

MDS is the FDA product code for sensor, glucose, invasive. It is a Class III device, reviewed by the Clinical Chemistry panel. Devices under MDS reach the market by PMA; FDA lists no cleared 510(k)s for it. 11 PMA applications cite this product code. FDA has posted 57 recalls for MDS devices, 2 initiated in the last five years.

Definition

The device is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

Classification

Recalls for MDS devices

57 product recalls in 14 recall events; 2 initiated in the last five years and 24 still open. Most recent: 2025-05-07.

Frequently asked questions

What is FDA product code MDS?

MDS is the FDA product code for sensor, glucose, invasive. It is a Class III device, reviewed by the Clinical Chemistry panel.

What device class is MDS?

Class III. Typical premarket route: PMA.

Have MDS devices been recalled?

Yes: 57 product recalls across 14 recall events; the most recent began 2025-05-07.

Next steps

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

All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times