FDA product code HBF: Drills, Burrs, Trephines & Accessories (Compound, Powered)
HBF is the FDA product code for drills, burrs, trephines & accessories (compound, powered). It is a Class II device, regulated under 21 CFR 882.4305 and reviewed by the Neurology panel. FDA has cleared 19 510(k) submissions under HBF, 3 in the last five years, from 11 different applicants. The average 510(k) review took 132 days (median 99); 279 days on average over the last three years. FDA has posted 6 recalls for HBF devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Drills, Burrs, Trephines & Accessories (Compound, Powered) |
| Device class | Class II |
| Regulation | 21 CFR 882.4305 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HBF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 30 |
| 2022 | 1 | 264 |
| 2024 | 1 | 296 |
| 2026 | 1 | 262 |
Compare with all 510(k) review times · Search every HBF clearance
Top HBF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Codman & Shurtleff, Inc. | 6 | 2008-01-04 |
| Acra Cut, Inc. | 3 | 2003-12-08 |
| The Anspach Effort, Inc. | 2 | 2008-12-22 |
| Guizhou Zirui Technology Co., Ltd. | 1 | 2026-09-11 |
| Evonos GmbH & Co. KG | 1 | 2024-03-06 |
6 more applicants have HBF clearances. See the full list in Caduvo.
Most recent HBF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254177 | Guizhou Zirui Technology Co., Ltd. | Disposable Sterile Skull Drill (LZ) | 2026-09-11 | 262 |
| K231403 | Evonos GmbH & Co. KG | evoDrill Cranial Perforator | 2024-03-06 | 296 |
| K213228 | Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | NeuroLine Disposable Cranial Perforator with Hudson end | 2022-06-20 | 264 |
| K183581 | Integra Lifesciences Corp. | Codman Disposable Perforators | 2019-01-20 | 30 |
| K141455 | Micromar Ind. Com. , Ltd. | EASYDRILL AUTOSTOP CRANIAL PERFORATOR | 2015-03-16 | 287 |
Recalls for HBF devices
6 product recalls in 4 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-09-26.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2025 | 4 |
Frequently asked questions
What is FDA product code HBF?
HBF is the FDA product code for drills, burrs, trephines & accessories (compound, powered). It is a Class II device, regulated under 21 CFR 882.4305 and reviewed by the Neurology panel.
What device class is HBF?
Class II, regulation 21 CFR 882.4305. Typical premarket route: 510(k).
How long does a 510(k) take for product code HBF?
Across 19 cleared submissions the average was 132 days from receipt to decision (median 99).
Which companies have the most HBF clearances?
Codman & Shurtleff, Inc. (6); Acra Cut, Inc. (3); The Anspach Effort, Inc. (2); Guizhou Zirui Technology Co., Ltd. (1); Evonos GmbH & Co. KG (1).
Have HBF devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2025-09-26.
Next steps
- Run an FDA pathway report with predicate devices for product code HBF
- Run a recall and safety report across every HBF manufacturer
- Watch product code HBF 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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