FDA product code QBL: Piston Syringe Lever
QBL is the FDA product code for piston syringe lever. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel. FDA has cleared 3 510(k) submissions under QBL. The average 510(k) review took 170 days (median 231).
Definition
Controlled compression of a piston syringe
Classification
| Field | Value |
|---|---|
| Device name | Piston Syringe Lever |
| Device class | Class II |
| Regulation | 21 CFR 880.5860 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for QBL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 251 |
| 2019 | 1 | 231 |
| 2020 | 1 | 27 |
Compare with all 510(k) review times · Search every QBL clearance
Top QBL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Urogen Pharma, Ltd. | 3 | 2020-12-09 |
Most recent QBL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203321 | Urogen Pharma, Ltd. | Cystoject Syringe Lever | 2020-12-09 | 27 |
| K190987 | Urogen Pharma, Ltd. | Uroject12 Syringe Lever | 2019-12-02 | 231 |
| K180345 | Urogen Pharma, Ltd. | Uroject12 Syringe Lever | 2018-10-17 | 251 |
Recalls for QBL devices
openFDA lists no recalls for product code QBL.
Frequently asked questions
What is FDA product code QBL?
QBL is the FDA product code for piston syringe lever. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel.
What device class is QBL?
Class II, regulation 21 CFR 880.5860. Typical premarket route: 510(k).
How long does a 510(k) take for product code QBL?
Across 3 cleared submissions the average was 170 days from receipt to decision (median 231).
Which companies have the most QBL clearances?
Urogen Pharma, Ltd. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code QBL
- Run a recall and safety report across every QBL manufacturer
- Watch product code QBL 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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