FDA product code QQI: Interventional Cardiovascular Implant Simulation Software Device
QQI is the FDA product code for interventional cardiovascular implant simulation software device. It is a Class II device, regulated under 21 CFR 870.1405 and reviewed by the Cardiovascular panel. FDA has cleared 3 510(k) submissions under QQI, 3 in the last five years, from 2 different applicants. The average 510(k) review took 163 days (median 161); 267 days on average over the last three years. 1 De Novo request was granted under it.
Definition
An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patients cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.
Classification
| Field | Value |
|---|---|
| Device name | Interventional Cardiovascular Implant Simulation Software Device |
| Device class | Class II |
| Regulation | 21 CFR 870.1405 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QQI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 60 |
| 2023 | 1 | 161 |
| 2025 | 1 | 267 |
Compare with all 510(k) review times · Search every QQI clearance
Top QQI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Feops NV | 2 | 2025-11-25 |
| Dasi Simulations | 1 | 2023-05-30 |
Most recent QQI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250635 | Feops NV | FEops HEARTguide Simulation Application | 2025-11-25 | 267 |
| K223809 | Dasi Simulations | PrecisionTAVI (v1.1) | 2023-05-30 | 161 |
| K214066 | Feops NV | FEops HEARTguide | 2022-02-25 | 60 |
Recalls for QQI devices
openFDA lists no recalls for product code QQI.
Frequently asked questions
What is FDA product code QQI?
QQI is the FDA product code for interventional cardiovascular implant simulation software device. It is a Class II device, regulated under 21 CFR 870.1405 and reviewed by the Cardiovascular panel.
What device class is QQI?
Class II, regulation 21 CFR 870.1405. Typical premarket route: 510(k).
How long does a 510(k) take for product code QQI?
Across 3 cleared submissions the average was 163 days from receipt to decision (median 161).
Which companies have the most QQI clearances?
Feops NV (2); Dasi Simulations (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QQI
- Run a recall and safety report across every QQI manufacturer
- Watch product code QQI 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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