FDA product code HBE: Drills, Burrs, Trephines & Accessories (Simple, Powered)
HBE is the FDA product code for drills, burrs, trephines & accessories (simple, powered). It is a Class II device, regulated under 21 CFR 882.4310 and reviewed by the Neurology panel. FDA has cleared 65 510(k) submissions under HBE, 11 in the last five years, from 38 different applicants. The average 510(k) review took 136 days (median 100); 102 days on average over the last three years. FDA has posted 258 recalls for HBE devices, 36 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class II |
| Regulation | 21 CFR 882.4310 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HBE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 227 |
| 2018 | 2 | 216 |
| 2019 | 5 | 159 |
| 2021 | 6 | 271 |
| 2022 | 2 | 184 |
| 2023 | 2 | 74 |
| 2025 | 6 | 78 |
| 2026 | 1 | 127 |
Compare with all 510(k) review times · Search every HBE clearance
Top HBE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Anspach Effort, Inc. | 7 | 2019-07-19 |
| Aesculap, Inc. | 5 | 2021-08-24 |
| Surgify Medical OY | 4 | 2026-03-26 |
| Stryker Corporation | 3 | 2021-06-30 |
| Stryker Corp. | 3 | 2015-05-08 |
33 more applicants have HBE clearances. See the full list in Caduvo.
Most recent HBE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253627 | Surgify Medical OY | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) | 2026-03-26 | 127 |
| K250815 | Hubly, Inc. | Hubly Drill (H100) | 2025-11-06 | 234 |
| K252060 | Phasor Health, LLC | GREEN | 2025-10-31 | 122 |
| K252662 | Nakanishi, Inc. | UniBur | 2025-09-19 | 28 |
| K251433 | Surgify Medical OY | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) | 2025-06-04 | 27 |
Recalls for HBE devices
258 product recalls in 34 recall events; 36 initiated in the last five years and 27 still open. Most recent: 2026-04-30.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 11 |
| 2025 | 2 |
| 2026 | 19 |
Frequently asked questions
What is FDA product code HBE?
HBE is the FDA product code for drills, burrs, trephines & accessories (simple, powered). It is a Class II device, regulated under 21 CFR 882.4310 and reviewed by the Neurology panel.
What device class is HBE?
Class II, regulation 21 CFR 882.4310. Typical premarket route: 510(k).
How long does a 510(k) take for product code HBE?
Across 65 cleared submissions the average was 136 days from receipt to decision (median 100).
Which companies have the most HBE clearances?
The Anspach Effort, Inc. (7); Aesculap, Inc. (5); Surgify Medical OY (4); Stryker Corporation (3); Stryker Corp. (3).
Have HBE devices been recalled?
Yes: 258 product recalls across 34 recall events; the most recent began 2026-04-30.
Next steps
- Run an FDA pathway report with predicate devices for product code HBE
- Run a recall and safety report across every HBE manufacturer
- Watch product code HBE 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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