FDA product code HCC: Device, Biofeedback
HCC is the FDA product code for device, biofeedback. It is a Class II device, regulated under 21 CFR 882.5050 and reviewed by the Neurology panel. FDA has cleared 172 510(k) submissions under HCC, 2 in the last five years, from 98 different applicants. The average 510(k) review took 176 days (median 90); 268 days on average over the last three years. FDA has posted 4 recalls for HCC devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Biofeedback |
| Device class | Class II |
| Regulation | 21 CFR 882.5050 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for HCC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 267 |
| 2018 | 1 | 213 |
| 2023 | 1 | 242 |
| 2024 | 1 | 268 |
Compare with all 510(k) review times · Search every HCC clearance
Top HCC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Thought Technology , Ltd. | 14 | 1992-09-09 |
| Bio-Feedback Systems, Inc. | 9 | 1991-04-12 |
| Moe | 6 | 1989-03-23 |
| Fasstech | 5 | 2001-09-20 |
| Verimed Holdings, Inc. | 5 | 1995-11-14 |
93 more applicants have HCC clearances. See the full list in Caduvo.
Most recent HCC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233580 | Deepwell Dtx, Inc. | A Breathing System (ABS) | 2024-08-01 | 268 |
| K222101 | Graymatters Health , Ltd. | Prism | 2023-03-17 | 242 |
| K180173 | Palo Alto Health Sciences, Inc. | Freespira | 2018-08-23 | 213 |
| K163448 | Sunstar Suisse S.A. | GrindCare System | 2017-09-01 | 267 |
| K151050 | Power Medical Devices, LLC | Pacifier Activated Lullaby (PAL®) | 2015-12-22 | 246 |
Recalls for HCC devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2023-12-11.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code HCC?
HCC is the FDA product code for device, biofeedback. It is a Class II device, regulated under 21 CFR 882.5050 and reviewed by the Neurology panel.
What device class is HCC?
Class II, regulation 21 CFR 882.5050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HCC?
Across 172 cleared submissions the average was 176 days from receipt to decision (median 90).
Which companies have the most HCC clearances?
Thought Technology , Ltd. (14); Bio-Feedback Systems, Inc. (9); Moe (6); Fasstech (5); Verimed Holdings, Inc. (5).
Have HCC devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2023-12-11.
Next steps
- Run an FDA pathway report with predicate devices for product code HCC
- Run a recall and safety report across every HCC manufacturer
- Watch product code HCC 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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