FDA product code HBB: Motor, Drill, Pneumatic
HBB is the FDA product code for motor, drill, pneumatic. It is a Class II device, regulated under 21 CFR 882.4370 and reviewed by the Neurology panel. FDA has cleared 27 510(k) submissions under HBB, 1 in the last five years, from 19 different applicants. The average 510(k) review took 138 days (median 90); 100 days on average over the last three years. FDA has posted 18 recalls for HBB devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Motor, Drill, Pneumatic |
| Device class | Class II |
| Regulation | 21 CFR 882.4370 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HBB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 129 |
| 2018 | 1 | 410 |
| 2026 | 1 | 100 |
Compare with all 510(k) review times · Search every HBB clearance
Top HBB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Anspach Effort, Inc. | 3 | 2007-01-26 |
| Sodemsystems | 3 | 2002-11-25 |
| Midas Rex Pneumatic Tools, Inc. | 3 | 1997-09-12 |
| Aesculap, Inc. | 2 | 2018-11-09 |
| Medtronic Powered Surgical Solutions | 2 | 2017-03-23 |
14 more applicants have HBB clearances. See the full list in Caduvo.
Most recent HBB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253772 | Adeor Medical AG | Velocity Alpha MR High Speed Surgical Drill System | 2026-03-06 | 100 |
| K172907 | Aesculap, Inc. | ELAN 4 Air Motor System | 2018-11-09 | 410 |
| K163182 | Medtronic Powered Surgical Solutions | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories | 2017-03-23 | 129 |
| K150801 | Stryker Corporation | Stryker Maestro Air Motors | 2015-05-22 | 57 |
| K101168 | Medtronic Sofamor Danek | LEGEND POWER ADAPTER MODEL: 6475000 | 2010-08-24 | 120 |
Recalls for HBB devices
18 product recalls in 14 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-08-18.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code HBB?
HBB is the FDA product code for motor, drill, pneumatic. It is a Class II device, regulated under 21 CFR 882.4370 and reviewed by the Neurology panel.
What device class is HBB?
Class II, regulation 21 CFR 882.4370. Typical premarket route: 510(k).
How long does a 510(k) take for product code HBB?
Across 27 cleared submissions the average was 138 days from receipt to decision (median 90).
Which companies have the most HBB clearances?
The Anspach Effort, Inc. (3); Sodemsystems (3); Midas Rex Pneumatic Tools, Inc. (3); Aesculap, Inc. (2); Medtronic Powered Surgical Solutions (2).
Have HBB devices been recalled?
Yes: 18 product recalls across 14 recall events; the most recent began 2025-08-18.
Next steps
- Run an FDA pathway report with predicate devices for product code HBB
- Run a recall and safety report across every HBB manufacturer
- Watch product code HBB 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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