FDA product code QRM: Multiple Use Blood Lancet For Multiple Patient Use
QRM is the FDA product code for multiple use blood lancet for multiple patient use. It is a Class III device, regulated under 21 CFR 878.4850 and reviewed by the General and Plastic Surgery panel. Devices under QRM reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Classification
| Field | Value |
|---|---|
| Device name | Multiple Use Blood Lancet For Multiple Patient Use |
| Device class | Class III |
| Regulation | 21 CFR 878.4850 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | PMA |
Recalls for QRM devices
openFDA lists no recalls for product code QRM.
Frequently asked questions
What is FDA product code QRM?
QRM is the FDA product code for multiple use blood lancet for multiple patient use. It is a Class III device, regulated under 21 CFR 878.4850 and reviewed by the General and Plastic Surgery panel.
What device class is QRM?
Class III, regulation 21 CFR 878.4850. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QRM
- Run a recall and safety report across every QRM manufacturer
- Watch product code QRM 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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