510(k) · Cleared
ClearedevoDrill Cranial Perforator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evonos GmbH & Co. KG · HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)
Cleared on Mar 6, 2024 as substantially equivalent to K892866 (Acra Cut, Inc., 1989) and 1 other predicate after a 296-day review. Its family tree reaches back 2 generations to 1979. 2 later devices descend from it.
- Decided
- Mar 6, 2024
- Review
- 296 days
- Class
- Class II
- Product code
- HBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K791101 (1979). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK791101 Disposable Perforators, Jacobs, HudsonCodman & Shurtleff, Inc. · 1979
- 1 generation backK933894 Disposable PerforatorCodman & Shurtleff, Inc. · 1993
- This deviceK231403 evoDrill Cranial PerforatorEvonos GmbH & Co. KG · 2024
- Descendant · cites it directly · 0 of its ownK254174 Surgical Power SystemGuizhou Zirui Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK254177 Disposable Sterile Skull Drill (LZ)Guizhou Zirui Technology Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K791101 | Disposable Perforators, Jacobs, Hudson | Codman & Shurtleff, Inc. | 1979 | — |
| −1 | K933894 | Disposable Perforator | Codman & Shurtleff, Inc. | 1993 | — |
| 0 (this device) | K231403 | evoDrill Cranial Perforator | Evonos GmbH & Co. KG | 2024 | — |
| +1 | K254174 | Surgical Power System | Guizhou Zirui Technology Co., Ltd. | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 K254177 Disposable Sterile Skull Drill (LZ)score 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K892866 | Automatic Cranial Drill (Perforator)Summary page 5…gulation Number: 21 CFR 882.4305 Predicate Device Names (21 CFR 807.92(a)(3)) - Acra Cut Automatic Cranial Drill (DGR-1 #200-241; DGR-II #200-251) (K892866) (Primary) - Codman Disposable Perforators 26-1221 (K933894)… | 1989 |
| * | K933894 | Disposable PerforatorSummary page 5…ames (21 CFR 807.92(a)(3)) - Acra Cut Automatic Cranial Drill (DGR-1 #200-241; DGR-II #200-251) (K892866) (Primary) - Codman Disposable Perforators 26-1221 (K933894) K231403 Page 2 of 5… | 1993 |
What descends from it? (2)
2 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?
- The line of descent spans 45 years and passes through 2 companies; a new generation was cleared every 30.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K254174 (Guizhou Zirui Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K892866.
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. 2024, 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?
The evoDrill Cranial Perforators are single-use surgical devices for cranium perforation. The perforators with the 3mm step automatically release and stop perforating at cranial bone thickness of at least 3mm. The perforators with the 1mm step automatically release and stop perforating at cranial bone thickness of at least 1mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231403: evoDrill Cranial Perforator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231403
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026