FDA product code FYD: Apparatus, Exhaust, Surgical
FYD is the FDA product code for apparatus, exhaust, surgical. It is a Class II device, regulated under 21 CFR 878.5070 and reviewed by the General Hospital panel. FDA has cleared 75 510(k) submissions under FYD, 3 in the last five years, from 47 different applicants. The average 510(k) review took 194 days (median 176); 168 days on average over the last three years. FDA has posted 23 recalls for FYD devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Exhaust, Surgical |
| Device class | Class II |
| Regulation | 21 CFR 878.5070 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FYD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 307 |
| 2018 | 1 | 231 |
| 2019 | 3 | 92 |
| 2020 | 1 | 144 |
| 2021 | 1 | 176 |
| 2022 | 1 | 102 |
| 2024 | 2 | 168 |
Compare with all 510(k) review times · Search every FYD clearance
Top FYD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Buffalo Filter Co., Inc. | 21 | 2014-03-03 |
| I.C Medical, Inc. | 5 | 2017-10-30 |
| Conmed Corporation | 2 | 2024-08-05 |
| Megadyne Medical Products, Inc. | 2 | 2020-06-26 |
| Quinn Healthcare Products | 2 | 1992-10-01 |
42 more applicants have FYD clearances. See the full list in Caduvo.
Most recent FYD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240127 | Conmed Corporation | PlumeSafe X5 Smoke Management System | 2024-08-05 | 201 |
| K233789 | Surnic Corporation | 8Q10 Surclear Smoke Plume Evacuation System | 2024-04-10 | 134 |
| K213068 | Medline Industries, Inc. | Medline Smoke Evacuation Shroud | 2022-01-03 | 102 |
| K202944 | Northgate Technologies, Inc. | NEBULAE SRS Laparoscopic Surgical Smoke Removal System | 2021-03-25 | 176 |
| K200250 | Megadyne Medical Products, Inc. | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor | 2020-06-26 | 144 |
Recalls for FYD devices
23 product recalls in 9 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-03-16.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code FYD?
FYD is the FDA product code for apparatus, exhaust, surgical. It is a Class II device, regulated under 21 CFR 878.5070 and reviewed by the General Hospital panel.
What device class is FYD?
Class II, regulation 21 CFR 878.5070. Typical premarket route: 510(k).
How long does a 510(k) take for product code FYD?
Across 75 cleared submissions the average was 194 days from receipt to decision (median 176).
Which companies have the most FYD clearances?
Buffalo Filter Co., Inc. (21); I.C Medical, Inc. (5); Conmed Corporation (2); Megadyne Medical Products, Inc. (2); Quinn Healthcare Products (2).
Have FYD devices been recalled?
Yes: 23 product recalls across 9 recall events; the most recent began 2026-03-16.
Next steps
- Run an FDA pathway report with predicate devices for product code FYD
- Run a recall and safety report across every FYD manufacturer
- Watch product code FYD 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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