FDA product code QKM: A Chemical Vapor Sterilization Multivariable Chemical Indicator
QKM is the FDA product code for a chemical vapor sterilization multivariable chemical indicator. It is a Class II device, regulated under 21 CFR 880.2800 and reviewed by the General Hospital panel. FDA has cleared 5 510(k) submissions under QKM, 3 in the last five years, from 4 different applicants. The average 510(k) review took 162 days (median 122); 266 days on average over the last three years.
Definition
A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.
Classification
| Field | Value |
|---|---|
| Device name | A Chemical Vapor Sterilization Multivariable Chemical Indicator |
| Device class | Class II |
| Regulation | 21 CFR 880.2800 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for QKM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 2 | 75 |
| 2022 | 2 | 197 |
| 2024 | 1 | 266 |
Compare with all 510(k) review times · Search every QKM clearance
Top QKM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 3M Company | 2 | 2022-04-20 |
| Terragene S.A. | 1 | 2024-04-05 |
| STERIS Corporation | 1 | 2022-01-07 |
| 3M Healthcare | 1 | 2020-03-13 |
Most recent QKM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232103 | Terragene S.A. | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | 2024-04-05 | 266 |
| K212022 | 3M Company | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 2022-04-20 | 295 |
| K213262 | STERIS Corporation | CELERITY HP Chemical Indicator | 2022-01-07 | 99 |
| K203284 | 3M Company | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator | 2020-12-07 | 28 |
| K193110 | 3M Healthcare | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 2020-03-13 | 122 |
Recalls for QKM devices
openFDA lists no recalls for product code QKM.
Frequently asked questions
What is FDA product code QKM?
QKM is the FDA product code for a chemical vapor sterilization multivariable chemical indicator. It is a Class II device, regulated under 21 CFR 880.2800 and reviewed by the General Hospital panel.
What device class is QKM?
Class II, regulation 21 CFR 880.2800. Typical premarket route: 510(k).
How long does a 510(k) take for product code QKM?
Across 5 cleared submissions the average was 162 days from receipt to decision (median 122).
Which companies have the most QKM clearances?
3M Company (2); Terragene S.A. (1); STERIS Corporation (1); 3M Healthcare (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QKM
- Run a recall and safety report across every QKM manufacturer
- Watch product code QKM 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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