FDA product code MEC: Disinfector, Medical Devices
MEC is the FDA product code for disinfector, medical devices. It is a Class II device, regulated under 21 CFR 880.6992 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under MEC, from 2 different applicants. The average 510(k) review took 562 days (median 562). FDA has posted 31 recalls for MEC devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Disinfector, Medical Devices |
| Device class | Class II |
| Regulation | 21 CFR 880.6992 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MEC clearance
Top MEC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympic Medical Corp. | 1 | 2008-06-20 |
| Hamo USA, Inc. | 1 | 1994-02-03 |
Most recent MEC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K081094 | Olympic Medical Corp. | OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 | 2008-06-20 | 64 |
| K911120 | Hamo USA, Inc. | DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21 | 1994-02-03 | 1060 |
Recalls for MEC devices
31 product recalls in 24 recall events; 10 initiated in the last five years and 9 still open. Most recent: 2025-11-19.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 5 |
| 2019 | 2 |
| 2020 | 5 |
| 2022 | 4 |
| 2023 | 1 |
| 2025 | 5 |
Frequently asked questions
What is FDA product code MEC?
MEC is the FDA product code for disinfector, medical devices. It is a Class II device, regulated under 21 CFR 880.6992 and reviewed by the General Hospital panel.
What device class is MEC?
Class II, regulation 21 CFR 880.6992. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MEC?
Across 2 cleared submissions the average was 562 days from receipt to decision (median 562).
Which companies have the most MEC clearances?
Olympic Medical Corp. (1); Hamo USA, Inc. (1).
Have MEC devices been recalled?
Yes: 31 product recalls across 24 recall events; the most recent began 2025-11-19.
Next steps
- Run an FDA pathway report with predicate devices for product code MEC
- Run a recall and safety report across every MEC manufacturer
- Watch product code MEC 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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