FDA product code QEW: Peripheral Mechanical Thrombectomy With Aspiration
QEW is the FDA product code for peripheral mechanical thrombectomy with aspiration. It is a Class II device, regulated under 21 CFR 870.5150 and reviewed by the Cardiovascular panel. FDA has cleared 145 510(k) submissions under QEW, 72 in the last five years, from 44 different applicants. The average 510(k) review took 105 days (median 78); 97 days on average over the last three years. FDA has posted 10 recalls for QEW devices, 10 initiated in the last five years.
Definition
To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.
Classification
| Field | Value |
|---|---|
| Device name | Peripheral Mechanical Thrombectomy With Aspiration |
| Device class | Class II |
| Regulation | 21 CFR 870.5150 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QEW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 44 |
| 2018 | 14 | 65 |
| 2019 | 8 | 66 |
| 2020 | 16 | 129 |
| 2021 | 11 | 90 |
| 2022 | 12 | 136 |
| 2023 | 23 | 110 |
| 2024 | 14 | 81 |
| 2025 | 14 | 78 |
| 2026 | 9 | 133 |
Compare with all 510(k) review times · Search every QEW clearance
Top QEW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Penumbra, Inc. | 26 | 2026-04-24 |
| Inari Medical, Inc. | 25 | 2026-09-18 |
| Inari Medical | 24 | 2025-10-29 |
| Inquis Medical | 5 | 2025-06-13 |
| Surmodics,Inc. | 5 | 2024-09-11 |
39 more applicants have QEW clearances. See the full list in Caduvo.
Most recent QEW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253419 | Inari Medical, Inc. | Triever Duo Catheter | 2026-09-18 | 352 |
| K261800 | Endovascular Engineering | Helo Max Thrombectomy System (HEL2090) | 2026-09-03 | 94 |
| K262538 | Inari Medical, Inc. | Artix MT;Artix Thin-Walled Sheath | 2026-08-21 | 29 |
| K261523 | Jupiter Endovascular | Vertex Thrombectomy System | 2026-08-04 | 89 |
| K260599 | Penumbra, Inc. | INDIGO® Aspiration System INDIGO Link | 2026-04-24 | 59 |
Recalls for QEW devices
10 product recalls in 4 recall events; 10 initiated in the last five years and 3 still open. Most recent: 2025-04-08.
| Year | Recalls |
|---|---|
| 2022 | 7 |
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code QEW?
QEW is the FDA product code for peripheral mechanical thrombectomy with aspiration. It is a Class II device, regulated under 21 CFR 870.5150 and reviewed by the Cardiovascular panel.
What device class is QEW?
Class II, regulation 21 CFR 870.5150. Typical premarket route: 510(k).
How long does a 510(k) take for product code QEW?
Across 145 cleared submissions the average was 105 days from receipt to decision (median 78).
Which companies have the most QEW clearances?
Penumbra, Inc. (26); Inari Medical, Inc. (25); Inari Medical (24); Inquis Medical (5); Surmodics,Inc. (5).
Have QEW devices been recalled?
Yes: 10 product recalls across 4 recall events; the most recent began 2025-04-08.
Next steps
- Run an FDA pathway report with predicate devices for product code QEW
- Run a recall and safety report across every QEW manufacturer
- Watch product code QEW 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