FDA product code HCB: Device, Aversive Conditioning
HCB is the FDA product code for device, aversive conditioning. It is a Class II device, regulated under 21 CFR 882.5235 and reviewed by the Neurology panel. FDA has cleared 6 510(k) submissions under HCB, from 6 different applicants. The average 510(k) review took 285 days (median 66).
Classification
| Field | Value |
|---|---|
| Device name | Device, Aversive Conditioning |
| Device class | Class II |
| Regulation | 21 CFR 882.5235 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HCB clearance
Top HCB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Behavior Research Institute, Inc. | 1 | 1994-12-05 |
| Human Technologies, Inc. | 1 | 1987-05-29 |
| Oxford Medilog, Inc. | 1 | 1986-02-28 |
| Michael R. Kiss | 1 | 1982-04-09 |
| Jackson Ent. | 1 | 1979-06-20 |
1 more applicants have HCB clearances. See the full list in Caduvo.
Most recent HCB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K911820 | Behavior Research Institute, Inc. | GED (GRADUATED ELECTRONIC DECELERATOR | 1994-12-05 | 1321 |
| K871158 | Human Technologies, Inc. | SIBIS REMOTE ACTUATOR | 1987-05-29 | 66 |
| K853178 | Oxford Medilog, Inc. | SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM | 1986-02-28 | 213 |
| K820622 | Michael R. Kiss | ELECTROSTIMULI AVERSION MACHINE | 1982-04-09 | 32 |
| K790738 | Jackson Ent. | HABITSABATER | 1979-06-20 | 65 |
Recalls for HCB devices
openFDA lists no recalls for product code HCB.
Frequently asked questions
What is FDA product code HCB?
HCB is the FDA product code for device, aversive conditioning. It is a Class II device, regulated under 21 CFR 882.5235 and reviewed by the Neurology panel.
What device class is HCB?
Class II, regulation 21 CFR 882.5235. Typical premarket route: 510(k).
How long does a 510(k) take for product code HCB?
Across 6 cleared submissions the average was 285 days from receipt to decision (median 66).
Which companies have the most HCB clearances?
Behavior Research Institute, Inc. (1); Human Technologies, Inc. (1); Oxford Medilog, Inc. (1); Michael R. Kiss (1); Jackson Ent. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HCB
- Run a recall and safety report across every HCB manufacturer
- Watch product code HCB 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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