FDA product code FSM: Tray, Surgical, Instrument
FSM is the FDA product code for tray, surgical, instrument. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 76 510(k) submissions under FSM, from 55 different applicants. The average 510(k) review took 66 days (median 42). FDA has posted 36 recalls for FSM devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tray, Surgical, Instrument |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| 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 FSM clearance
Top FSM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medcare Products | 5 | 1984-04-25 |
| Medical Device Inspection Co., Inc. | 4 | 1991-08-29 |
| Ascep, Inc. | 4 | 1983-04-12 |
| Medical Sterilization, Inc. | 3 | 1984-10-31 |
| E.M. Adams | 3 | 1984-10-23 |
50 more applicants have FSM clearances. See the full list in Caduvo.
Most recent FSM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971217 | General Hospital Supply Corp. | INSTRUMENT TRAY LINER | 1997-05-06 | 34 |
| K962328 | Medcare Medical Group, Inc. | SINGLE USE INSTRUMENT TRAY | 1996-08-09 | 64 |
| K944025 | Riley Medical, Inc. | SURGICAL INSTRUMENT TRAY | 1994-11-22 | 97 |
| K912106 | Medical Device Inspection Co., Inc. | ARTHROSCOPY TRAY | 1991-08-29 | 108 |
| K912053 | Medical Device Inspection Co., Inc. | OPEN HEART TRAY | 1991-08-26 | 109 |
Recalls for FSM devices
36 product recalls in 22 recall events; 8 initiated in the last five years and 8 still open. Most recent: 2025-07-18.
| Year | Recalls |
|---|---|
| 2018 | 5 |
| 2019 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code FSM?
FSM is the FDA product code for tray, surgical, instrument. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is FSM?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FSM?
Across 76 cleared submissions the average was 66 days from receipt to decision (median 42).
Which companies have the most FSM clearances?
Medcare Products (5); Medical Device Inspection Co., Inc. (4); Ascep, Inc. (4); Medical Sterilization, Inc. (3); E.M. Adams (3).
Have FSM devices been recalled?
Yes: 36 product recalls across 22 recall events; the most recent began 2025-07-18.
Next steps
- Run an FDA pathway report with predicate devices for product code FSM
- Run a recall and safety report across every FSM manufacturer
- Watch product code FSM 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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