FDA product code PYV: Hospital Continuous Glucose Monitoring System
PYV is the FDA product code for hospital continuous glucose monitoring system. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel. Devices under PYV reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Intended for the continuous, quantitative measurement of glucose in whole blood in a hospital setting.
Classification
| Field | Value |
|---|---|
| Device name | Hospital Continuous Glucose Monitoring System |
| Device class | Class II |
| Regulation | 21 CFR 862.1345 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
Recalls for PYV devices
openFDA lists no recalls for product code PYV.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0422 — Intensive cardiac rehabilitation; with or without continuous ecg monitoring with exercise, per session
- G0423 — Intensive cardiac rehabilitation; with or without continuous ecg monitoring; without exercise, per session
Frequently asked questions
What is FDA product code PYV?
PYV is the FDA product code for hospital continuous glucose monitoring system. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel.
What device class is PYV?
Class II, regulation 21 CFR 862.1345. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PYV
- Run a recall and safety report across every PYV manufacturer
- Watch product code PYV 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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