FDA product code MTC: Indicator, Chemical, Enzymatic, Sterilization Process
MTC is the FDA product code for indicator, chemical, enzymatic, sterilization process. It is a Class II device, regulated under 21 CFR 880.2800 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under MTC, from 2 different applicants. The average 510(k) review took 372 days (median 372).
Classification
| Field | Value |
|---|---|
| Device name | Indicator, Chemical, Enzymatic, Sterilization Process |
| Device class | Class II |
| Regulation | 21 CFR 880.2800 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MTC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 298 |
Compare with all 510(k) review times · Search every MTC clearance
Top MTC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| True Indicating, LLC | 1 | 2021-12-14 |
| North American Science Assoc., Inc. | 1 | 1997-09-26 |
Most recent MTC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K210481 | True Indicating, LLC | Instant 20s Indicator | 2021-12-14 | 298 |
| K962649 | North American Science Assoc., Inc. | SPORTROL RAPID STERILITY INDICATOR | 1997-09-26 | 445 |
Recalls for MTC devices
openFDA lists no recalls for product code MTC.
Frequently asked questions
What is FDA product code MTC?
MTC is the FDA product code for indicator, chemical, enzymatic, sterilization process. It is a Class II device, regulated under 21 CFR 880.2800 and reviewed by the General Hospital panel.
What device class is MTC?
Class II, regulation 21 CFR 880.2800. Typical premarket route: 510(k).
How long does a 510(k) take for product code MTC?
Across 2 cleared submissions the average was 372 days from receipt to decision (median 372).
Which companies have the most MTC clearances?
True Indicating, LLC (1); North American Science Assoc., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MTC
- Run a recall and safety report across every MTC manufacturer
- Watch product code MTC 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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