FDA product code QWF: Tubing, Long Term Support Greater Than 6 Hours
QWF is the FDA product code for tubing, long term support greater than 6 hours. It is a Class II device, regulated under 21 CFR 870.4100 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under QWF, 1 in the last five years. The average 510(k) review took 190 days (median 190).
Definition
The tubing and accessories are intended to connect perfusion devices and circulate blood as part of extracorporeal membrane oxygenation lasting longer than 6 hours.
Classification
| Field | Value |
|---|---|
| Device name | Tubing, Long Term Support Greater Than 6 Hours |
| Device class | Class II |
| Regulation | 21 CFR 870.4100 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for QWF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 190 |
Compare with all 510(k) review times · Search every QWF clearance
Top QWF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic, Inc. | 1 | 2023-04-19 |
Most recent QWF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223168 | Medtronic, Inc. | Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface | 2023-04-19 | 190 |
Recalls for QWF devices
openFDA lists no recalls for product code QWF.
Frequently asked questions
What is FDA product code QWF?
QWF is the FDA product code for tubing, long term support greater than 6 hours. It is a Class II device, regulated under 21 CFR 870.4100 and reviewed by the Cardiovascular panel.
What device class is QWF?
Class II, regulation 21 CFR 870.4100. Typical premarket route: 510(k).
How long does a 510(k) take for product code QWF?
Across 1 cleared submissions the average was 190 days from receipt to decision (median 190).
Which companies have the most QWF clearances?
Medtronic, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QWF
- Run a recall and safety report across every QWF manufacturer
- Watch product code QWF 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times