FDA product code PHV: Continuous Glucose Monitor Retrospective Data Analysis Software

PHV is the FDA product code for continuous glucose monitor retrospective data analysis software. It is a Class I device, regulated under 21 CFR 862.2120 and reviewed by the Clinical Chemistry panel. Devices under PHV reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it. FDA has posted 2 recalls for PHV devices, 1 initiated in the last five years.

Definition

Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device.

Classification

Recalls for PHV devices

2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-10-21.

Frequently asked questions

What is FDA product code PHV?

PHV is the FDA product code for continuous glucose monitor retrospective data analysis software. It is a Class I device, regulated under 21 CFR 862.2120 and reviewed by the Clinical Chemistry panel.

What device class is PHV?

Class I, regulation 21 CFR 862.2120. Typical premarket route: 510(k) exempt.

Have PHV devices been recalled?

Yes: 2 product recalls across 2 recall events; the most recent began 2025-10-21.

Next steps

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