FDA product code PQM: Surgical Smoke Precipitator
PQM is the FDA product code for surgical smoke precipitator. It is a Class II device, regulated under 21 CFR 878.5050 and reviewed by the General Hospital panel. FDA has cleared 6 510(k) submissions under PQM, 3 in the last five years, from 2 different applicants. The average 510(k) review took 131 days (median 132); 136 days on average over the last three years. 1 De Novo request was granted under it.
Definition
The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools.
Classification
| Field | Value |
|---|---|
| Device name | Surgical Smoke Precipitator |
| Device class | Class II |
| Regulation | 21 CFR 878.5050 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for PQM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 127 |
| 2018 | 1 | 38 |
| 2020 | 1 | 117 |
| 2023 | 2 | 183 |
| 2024 | 1 | 136 |
Compare with all 510(k) review times · Search every PQM clearance
Top PQM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alesi Surgical, Ltd. | 5 | 2023-10-31 |
| Alesi Surgical Limited | 1 | 2024-08-12 |
Most recent PQM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240868 | Alesi Surgical Limited | Ultravision2 IonPencil | 2024-08-12 | 136 |
| K231298 | Alesi Surgical, Ltd. | Ultravision2 System Integrated Monopolar L-Hook (H/S) | 2023-10-31 | 180 |
| K231238 | Alesi Surgical, Ltd. | Ultravision2 System | 2023-10-31 | 186 |
| K200035 | Alesi Surgical, Ltd. | Ultravision Visual Field Clearing System | 2020-05-04 | 117 |
| K182053 | Alesi Surgical, Ltd. | Ultravision Visual Field Clearing System | 2018-09-07 | 38 |
Recalls for PQM devices
openFDA lists no recalls for product code PQM.
Frequently asked questions
What is FDA product code PQM?
PQM is the FDA product code for surgical smoke precipitator. It is a Class II device, regulated under 21 CFR 878.5050 and reviewed by the General Hospital panel.
What device class is PQM?
Class II, regulation 21 CFR 878.5050. Typical premarket route: 510(k).
How long does a 510(k) take for product code PQM?
Across 6 cleared submissions the average was 131 days from receipt to decision (median 132).
Which companies have the most PQM clearances?
Alesi Surgical, Ltd. (5); Alesi Surgical Limited (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PQM
- Run a recall and safety report across every PQM manufacturer
- Watch product code PQM 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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