FDA product code QTI: Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
QTI is the FDA product code for saline vascular access flush with integrated alcohol disinfectant device. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under QTI, 1 in the last five years. The average 510(k) review took 211 days (median 211).
Definition
Prefilled saline flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs.
Classification
| Field | Value |
|---|---|
| Device name | Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device |
| Device class | Class II |
| Regulation | 21 CFR 880.5200 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for QTI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 211 |
Compare with all 510(k) review times · Search every QTI clearance
Top QTI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Becton, Dickinson and Company | 1 | 2022-07-16 |
Most recent QTI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213955 | Becton, Dickinson and Company | 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub | 2022-07-16 | 211 |
Recalls for QTI devices
openFDA lists no recalls for product code QTI.
Frequently asked questions
What is FDA product code QTI?
QTI is the FDA product code for saline vascular access flush with integrated alcohol disinfectant device. It is a Class II device, regulated under 21 CFR 880.5200 and reviewed by the General Hospital panel.
What device class is QTI?
Class II, regulation 21 CFR 880.5200. Typical premarket route: 510(k).
How long does a 510(k) take for product code QTI?
Across 1 cleared submissions the average was 211 days from receipt to decision (median 211).
Which companies have the most QTI clearances?
Becton, Dickinson and Company (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QTI
- Run a recall and safety report across every QTI manufacturer
- Watch product code QTI 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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