FDA product code QMS: Adjunctive Open Loop Fluid Therapy Recommender
QMS is the FDA product code for adjunctive open loop fluid therapy recommender. It is a Class II device, regulated under 21 CFR 870.5600 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under QMS, 1 in the last five years. The average 510(k) review took 228 days (median 228); 228 days on average over the last three years. 1 De Novo request was granted under it.
Definition
The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patients estimated response to fluid therapy. The device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Classification
| Field | Value |
|---|---|
| Device name | Adjunctive Open Loop Fluid Therapy Recommender |
| Device class | Class II |
| Regulation | 21 CFR 870.5600 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for QMS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 228 |
Compare with all 510(k) review times · Search every QMS clearance
Top QMS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edwards Lifesciences, LLC | 1 | 2024-08-02 |
Most recent QMS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233984 | Edwards Lifesciences, LLC | Acumen Assisted Fluid Management (AFM) Software Feature | 2024-08-02 | 228 |
Recalls for QMS devices
openFDA lists no recalls for product code QMS.
Frequently asked questions
What is FDA product code QMS?
QMS is the FDA product code for adjunctive open loop fluid therapy recommender. It is a Class II device, regulated under 21 CFR 870.5600 and reviewed by the Cardiovascular panel.
What device class is QMS?
Class II, regulation 21 CFR 870.5600. Typical premarket route: 510(k).
How long does a 510(k) take for product code QMS?
Across 1 cleared submissions the average was 228 days from receipt to decision (median 228).
Which companies have the most QMS clearances?
Edwards Lifesciences, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QMS
- Run a recall and safety report across every QMS manufacturer
- Watch product code QMS 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