FDA product code PUR: Vacuum Syringe
PUR is the FDA product code for vacuum syringe. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under PUR, 1 in the last five years, from 2 different applicants. The average 510(k) review took 200 days (median 200); 182 days on average over the last three years.
Definition
The vacuum syringe is intended to be used as a general purpose syringe for injection and withdrawal of fluids and can be locked in place to create a vacuum for removal of fluid and/or tissue from the body in the form of thrombus, abscess fluid, and infected fluid.
Classification
| Field | Value |
|---|---|
| Device name | Vacuum Syringe |
| Device class | Class II |
| Regulation | 21 CFR 880.5860 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for PUR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 218 |
| 2024 | 1 | 182 |
Compare with all 510(k) review times · Search every PUR clearance
Top PUR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inari Medical, Inc. | 1 | 2024-03-26 |
| Merit Medical Systems, Inc. | 1 | 2017-07-27 |
Most recent PUR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233069 | Inari Medical, Inc. | Removal System Large Bore 60 cc Syringe | 2024-03-26 | 182 |
| K163597 | Merit Medical Systems, Inc. | VacLok AT Vacuum Syringe | 2017-07-27 | 218 |
Recalls for PUR devices
openFDA lists no recalls for product code PUR.
Frequently asked questions
What is FDA product code PUR?
PUR is the FDA product code for vacuum syringe. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel.
What device class is PUR?
Class II, regulation 21 CFR 880.5860. Typical premarket route: 510(k).
How long does a 510(k) take for product code PUR?
Across 2 cleared submissions the average was 200 days from receipt to decision (median 200).
Which companies have the most PUR clearances?
Inari Medical, Inc. (1); Merit Medical Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PUR
- Run a recall and safety report across every PUR manufacturer
- Watch product code PUR 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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