510(k) · Cleared
ClearedDisposable Sterile Skull Drill (LZ)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guizhou Zirui Technology Co., Ltd. · HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)
Cleared on Sep 11, 2026 as substantially equivalent to K231403 (Evonos GmbH & Co. KG, 2024) after a 262-day review. Its family tree reaches back 3 generations to 1979.
- Decided
- Sep 11, 2026
- Review
- 262 days
- Class
- Class II
- Product code
- HBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K791101 (1979). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK791101 Disposable Perforators, Jacobs, HudsonCodman & Shurtleff, Inc. · 1979
- 2 generations backK933894 Disposable PerforatorCodman & Shurtleff, Inc. · 1993
- 1 generation backK231403 evoDrill Cranial PerforatorEvonos GmbH & Co. KG · 2024
- This deviceK254177 Disposable Sterile Skull Drill (LZ)Guizhou Zirui Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K791101 | Disposable Perforators, Jacobs, Hudson | Codman & Shurtleff, Inc. | 1979 | — |
| −2 | K933894 | Disposable Perforator | Codman & Shurtleff, Inc. | 1993 | — |
| −1 | K231403 | evoDrill Cranial Perforator | Evonos GmbH & Co. KG | 2024 | — |
| 0 (this device) | K254177 | Disposable Sterile Skull Drill (LZ) | Guizhou Zirui Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K231403 | evoDrill Cranial PerforatorSummary page 6…Page 2 of 5 3. Legally Market Predicate Device Device Name: evonos evoDrill Cranial Perforator 510(k) Number K231403 Product Code: HBF Device Class Class 2 Manufacturer… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 47 years and passes through 3 companies; a new generation was cleared every 14.3 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K231403.
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. 2026, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Disposable Sterile Skull Drill is a sterile, single-use device intended for cranium perforation during neurosurgical procedures to establish surgical access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254177 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254177: Disposable Sterile Skull Drill (LZ).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254177
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026