FDA product code QVB: Biological Sterilization Indicator With Indirect Growth Detection
QVB is the FDA product code for biological sterilization indicator with indirect growth detection. It is a Class II device, regulated under 21 CFR 880.2806 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under QVB, 2 in the last five years, from 2 different applicants. The average 510(k) review took 332 days (median 332); 332 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A biological sterilization indicator with indirect growth detection capabilities is a device intended for use by a healthcare provider to accompany products being sterilized through a sterilization process to monitor the adequacy of sterilization. Detection of surviving microorganisms is accomplished by a method other than direct detection of growth or growth products.
Classification
| Field | Value |
|---|---|
| Device name | Biological Sterilization Indicator With Indirect Growth Detection |
| Device class | Class II |
| Regulation | 21 CFR 880.2806 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for QVB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 2 | 332 |
Compare with all 510(k) review times · Search every QVB clearance
Top QVB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| True Indicating, LLC | 1 | 2026-06-18 |
| Steritec Products | 1 | 2026-04-22 |
Most recent QVB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251559 | True Indicating, LLC | InstaTRU Instant Biological Indicator for Steam (IBI-05) | 2026-06-18 | 393 |
| K252306 | Steritec Products | Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA Auto-Reader (Model: 1100) | 2026-04-22 | 272 |
Recalls for QVB devices
openFDA lists no recalls for product code QVB.
Frequently asked questions
What is FDA product code QVB?
QVB is the FDA product code for biological sterilization indicator with indirect growth detection. It is a Class II device, regulated under 21 CFR 880.2806 and reviewed by the General Hospital panel.
What device class is QVB?
Class II, regulation 21 CFR 880.2806. Typical premarket route: 510(k).
How long does a 510(k) take for product code QVB?
Across 2 cleared submissions the average was 332 days from receipt to decision (median 332).
Which companies have the most QVB clearances?
True Indicating, LLC (1); Steritec Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QVB
- Run a recall and safety report across every QVB manufacturer
- Watch product code QVB 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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