FDA product code FSY: Light, Surgical, Ceiling Mounted
FSY is the FDA product code for light, surgical, ceiling mounted. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel. FDA has cleared 74 510(k) submissions under FSY, from 43 different applicants. The average 510(k) review took 73 days (median 62). FDA has posted 454 recalls for FSY devices, 25 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Light, Surgical, Ceiling Mounted |
| Device class | Class II |
| Regulation | 21 CFR 878.4580 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FSY clearance
Top FSY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Berchtold Holding GmbH | 9 | 2008-10-30 |
| Skytron, Div. the Kmw Group, Inc. | 6 | 2007-07-06 |
| Burton Medical Products Corp. | 5 | 2010-09-30 |
| Dr. Mach GmbH & Co. KG | 4 | 2014-04-03 |
| Kinetic Biomedical Services, Inc. | 3 | 1989-06-15 |
38 more applicants have FSY clearances. See the full list in Caduvo.
Most recent FSY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K142984 | Sunnex, Inc. | Leo Minor | 2014-10-29 | 13 |
| K142076 | Dickson & Dickson Healthcare (Us), Inc. | CLAVEGUARD FREEDOM SURGICAL LIGHT | 2014-09-30 | 61 |
| K140812 | Medical Illumination International, Inc. | MI-750 PROCEDURAL/MINOR SURGICAL LIGHT | 2014-08-07 | 128 |
| K132551 | Umbel Corporation | ZF 720 | 2014-06-30 | 320 |
| K140930 | Convida Healthcare & Systems Corporation | VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES | 2014-06-09 | 59 |
Recalls for FSY devices
454 product recalls in 45 recall events; 25 initiated in the last five years and 28 still open. Most recent: 2026-08-07.
| Year | Recalls |
|---|---|
| 2017 | 144 |
| 2018 | 4 |
| 2019 | 8 |
| 2022 | 1 |
| 2023 | 11 |
| 2024 | 5 |
| 2025 | 3 |
| 2026 | 5 |
Frequently asked questions
What is FDA product code FSY?
FSY is the FDA product code for light, surgical, ceiling mounted. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel.
What device class is FSY?
Class II, regulation 21 CFR 878.4580. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FSY?
Across 74 cleared submissions the average was 73 days from receipt to decision (median 62).
Which companies have the most FSY clearances?
Berchtold Holding GmbH (9); Skytron, Div. the Kmw Group, Inc. (6); Burton Medical Products Corp. (5); Dr. Mach GmbH & Co. KG (4); Kinetic Biomedical Services, Inc. (3).
Have FSY devices been recalled?
Yes: 454 product recalls across 45 recall events; the most recent began 2026-08-07.
Next steps
- Run an FDA pathway report with predicate devices for product code FSY
- Run a recall and safety report across every FSY manufacturer
- Watch product code FSY 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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