FDA product code QQC: Brain Stimulation Programming Planning Software.
QQC is the FDA product code for brain stimulation programming planning software.. It is a Class II device, regulated under 21 CFR 882.5855 and reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under QQC, 2 in the last five years, from 2 different applicants. The average 510(k) review took 130 days (median 130); 135 days on average over the last three years. 1 De Novo request was granted under it.
Definition
The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.
Classification
| Field | Value |
|---|---|
| Device name | Brain Stimulation Programming Planning Software. |
| Device class | Class II |
| Regulation | 21 CFR 882.5855 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for QQC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 124 |
| 2025 | 1 | 135 |
Compare with all 510(k) review times · Search every QQC clearance
Top QQC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Turing Medical Technologies, Inc. | 1 | 2025-03-28 |
| Brainlab AG | 1 | 2022-04-19 |
Most recent QQC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243520 | Turing Medical Technologies, Inc. | Bullsai Confirm | 2025-03-28 | 135 |
| K213930 | Brainlab AG | Brainlab Elements Guide XT, Guide 3.0 | 2022-04-19 | 124 |
Recalls for QQC devices
openFDA lists no recalls for product code QQC.
Frequently asked questions
What is FDA product code QQC?
QQC is the FDA product code for brain stimulation programming planning software.. It is a Class II device, regulated under 21 CFR 882.5855 and reviewed by the Neurology panel.
What device class is QQC?
Class II, regulation 21 CFR 882.5855. Typical premarket route: 510(k).
How long does a 510(k) take for product code QQC?
Across 2 cleared submissions the average was 130 days from receipt to decision (median 130).
Which companies have the most QQC clearances?
Turing Medical Technologies, Inc. (1); Brainlab AG (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QQC
- Run a recall and safety report across every QQC manufacturer
- Watch product code QQC 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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