FDA product code FQO: Table, Operating-Room, Ac-Powered
FQO is the FDA product code for table, operating-room, ac-powered. It is a Class I device, regulated under 21 CFR 878.4960 and reviewed by the General and Plastic Surgery panel. FDA has cleared 35 510(k) submissions under FQO, 2 in the last five years, from 23 different applicants. The average 510(k) review took 106 days (median 77); 91 days on average over the last three years. FDA has posted 73 recalls for FQO devices, 18 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Table, Operating-Room, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 878.4960 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
510(k) clearances per year for FQO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 200 |
| 2024 | 1 | 91 |
Compare with all 510(k) review times · Search every FQO clearance
Top FQO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alm Surgical Equipment, Inc. | 4 | 1996-07-30 |
| Moon Surgical | 2 | 2024-06-03 |
| STERIS Corporation | 2 | 2009-03-20 |
| Berchtold Holding GmbH | 2 | 1996-02-08 |
| Midmark Corp. | 2 | 1994-10-21 |
18 more applicants have FQO clearances. See the full list in Caduvo.
Most recent FQO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240598 | Moon Surgical | Maestro System (REF100) | 2024-06-03 | 91 |
| K221410 | Moon Surgical | Maestro Platform | 2022-12-02 | 200 |
| K090136 | STERIS Corporation | STERIS CMAX XLT SURGICAL TABLE | 2009-03-20 | 58 |
| K972810 | O.P.T. USA, Inc. | OPT80 THE TRANSPORTABLE (OPT80) | 1997-08-26 | 29 |
| K971988 | Allen Medical Systems, Inc. | ALLEN, ULTRA AND SMART SOCKETS | 1997-07-11 | 43 |
Recalls for FQO devices
73 product recalls in 48 recall events; 18 initiated in the last five years and 22 still open. Most recent: 2026-08-06.
| Year | Recalls |
|---|---|
| 2018 | 11 |
| 2020 | 3 |
| 2021 | 3 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 11 |
| 2025 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code FQO?
FQO is the FDA product code for table, operating-room, ac-powered. It is a Class I device, regulated under 21 CFR 878.4960 and reviewed by the General and Plastic Surgery panel.
What device class is FQO?
Class I, regulation 21 CFR 878.4960. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FQO?
Across 35 cleared submissions the average was 106 days from receipt to decision (median 77).
Which companies have the most FQO clearances?
Alm Surgical Equipment, Inc. (4); Moon Surgical (2); STERIS Corporation (2); Berchtold Holding GmbH (2); Midmark Corp. (2).
Have FQO devices been recalled?
Yes: 73 product recalls across 48 recall events; the most recent began 2026-08-06.
Next steps
- Run an FDA pathway report with predicate devices for product code FQO
- Run a recall and safety report across every FQO manufacturer
- Watch product code FQO 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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