FDA product code HBC: Motor, Drill, Electric
HBC is the FDA product code for motor, drill, electric. It is a Class II device, regulated under 21 CFR 882.4360 and reviewed by the Neurology panel. FDA has cleared 26 510(k) submissions under HBC, 4 in the last five years, from 15 different applicants. The average 510(k) review took 146 days (median 90); 360 days on average over the last three years. FDA has posted 39 recalls for HBC devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Motor, Drill, Electric |
| Device class | Class II |
| Regulation | 21 CFR 882.4360 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HBC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 101 |
| 2018 | 1 | 266 |
| 2019 | 1 | 145 |
| 2021 | 1 | 470 |
| 2022 | 2 | 216 |
| 2024 | 2 | 360 |
Top HBC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Anspach Effort, Inc. | 3 | 2022-05-19 |
| Medtronic Powered Surgical Solutions | 3 | 2019-05-12 |
| Aesculap, Inc. | 3 | 2016-07-22 |
| Saeshin Precision Co., Ltd. | 2 | 2024-09-20 |
| Bien-Air Surgery SA | 2 | 2022-10-31 |
10 more applicants have HBC clearances. See the full list in Caduvo.
Most recent HBC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233153 | Saeshin Precision Co., Ltd. | Traus SSG10 Surgical System | 2024-09-20 | 359 |
| K232938 | Saeshin Precision Co., Ltd. | Traus SSG30 Surgical System | 2024-09-16 | 362 |
| K213697 | Bien-Air Surgery SA | ORiGO System | 2022-10-31 | 342 |
| K220485 | The Anspach Effort, Inc. | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) | 2022-05-19 | 91 |
| K193630 | Zethon, Ltd. | hekaDrill | 2021-04-09 | 470 |
Recalls for HBC devices
39 product recalls in 11 recall events; 9 initiated in the last five years and 9 still open. Most recent: 2022-12-07.
| Year | Recalls |
|---|---|
| 2022 | 9 |
Frequently asked questions
What is FDA product code HBC?
HBC is the FDA product code for motor, drill, electric. It is a Class II device, regulated under 21 CFR 882.4360 and reviewed by the Neurology panel.
What device class is HBC?
Class II, regulation 21 CFR 882.4360. Typical premarket route: 510(k).
How long does a 510(k) take for product code HBC?
Across 26 cleared submissions the average was 146 days from receipt to decision (median 90).
Which companies have the most HBC clearances?
The Anspach Effort, Inc. (3); Medtronic Powered Surgical Solutions (3); Aesculap, Inc. (3); Saeshin Precision Co., Ltd. (2); Bien-Air Surgery SA (2).
Have HBC devices been recalled?
Yes: 39 product recalls across 11 recall events; the most recent began 2022-12-07.
Next steps
- Run an FDA pathway report with predicate devices for product code HBC
- Run a recall and safety report across every HBC manufacturer
- Watch product code HBC 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.