510(k) · Cleared
ClearedAutomatic Cranial Drill (Perforator)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acra Cut, Inc. · HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)
Cleared on Jun 15, 1989 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jun 15, 1989
- Review
- 57 days
- Class
- Class II
- Product code
- HBF
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK892866 Automatic Cranial Drill (Perforator)Acra Cut, Inc. · 1989
- Descendant · cites it directly · 2 of its ownK231403 evoDrill Cranial PerforatorEvonos GmbH & Co. KG · 2024
- Descendant · cites it directly · 1 of its ownK082010 Stryker Disposable Cranial Perforator BitStryker Ireland Ltd., Instruments Division · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK254174 Surgical Power SystemGuizhou Zirui Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK254177 Disposable Sterile Skull Drill (LZ)Guizhou Zirui Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK141455 Easydrill Autostop Cranial PerforatorMicromar Ind. Com., Ltd. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K231403evoDrill Cranial PerforatorEvonos GmbH & Co. KG · 2024 · cites it directly2descendants
- K082010Stryker Disposable Cranial Perforator BitStryker Ireland Ltd., Instruments Division · 2008 · cites it directly1descendant
- K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K254177Disposable Sterile Skull Drill (LZ)Guizhou Zirui Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K141455Easydrill Autostop Cranial PerforatorMicromar Ind. Com., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K892866 | Automatic Cranial Drill (Perforator) | Acra Cut, Inc. | 1989 | — |
| +1 | K231403 | evoDrill Cranial Perforator | Evonos GmbH & Co. KG | 2024 | — |
| +1 | K082010 | Stryker Disposable Cranial Perforator Bit | Stryker Ireland Ltd., Instruments Division | 2008 | 1 |
| +2 | K254174 | Surgical Power System | Guizhou Zirui Technology Co., Ltd. | 2026 | — |
| +2 | K254177 | Disposable Sterile Skull Drill (LZ) | Guizhou Zirui Technology Co., Ltd. | 2026 | — |
| +1 | K141455 | Easydrill Autostop Cranial Perforator | Micromar Ind. Com., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2015 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HBF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HBF device
- #1 K231403 evoDrill Cranial Perforatorscore 13.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K231403 (Evonos GmbH & Co. KG, 2024) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HBF devicesHBF Drills, Burrs, Trephines & Accessories (Compound, Powered): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HBF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HBF
103in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HBF
2in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · HBF
113in 2025
MAUDE reports naming product code HBF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 25 |
| 2008 | 3 | 103 | 0 | 41 |
| 2009 | 0 | — | 0 | 34 |
| 2010 | 0 | — | 0 | 73 |
| 2011 | 0 | — | 1 | 39 |
| 2012 | 1 | — | 0 | 79 |
| 2013 | 0 | — | 0 | 103 |
| 2014 | 0 | — | 0 | 95 |
| 2015 | 1 | — | 0 | 59 |
| 2016 | 0 | — | 0 | 76 |
| 2017 | 0 | — | 0 | 106 |
| 2018 | 0 | — | 0 | 136 |
| 2019 | 1 | — | 0 | 208 |
| 2020 | 0 | — | 1 | 324 |
| 2021 | 0 | — | 0 | 309 |
| 2022 | 1 | — | 0 | 148 |
| 2023 | 0 | — | 0 | 108 |
| 2024 | 1 | — | 0 | 179 |
| 2025 | 0 | — | 2 (2) | 113 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K892866 · printed Nov 4, 2026
Cite this page
510(k) Report. “K892866: Automatic Cranial Drill (Perforator).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K892866
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026