510(k) · Cleared
ClearedDisposable Perforator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)
Cleared on Dec 10, 1993 as substantially equivalent to K791101 (Codman & Shurtleff, Inc., 1979) and 1 other predicate after a 122-day review. Its family tree reaches back 1 generation to 1979. 5 later devices descend from it.
- Decided
- Dec 10, 1993
- Review
- 122 days
- Class
- Class II
- Product code
- HBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K791101 (1979). 2 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK791101 Disposable Perforators, Jacobs, HudsonCodman & Shurtleff, Inc. · 1979
- This deviceK933894 Disposable PerforatorCodman & Shurtleff, Inc. · 1993
- Descendant · cites it directly · 2 of its ownK231403 evoDrill Cranial PerforatorEvonos GmbH & Co. KG · 2024
- 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 ownK121253 Meridian Cranial PerforatorAdeor Medical Technologies GmbH · 2012
- Descendant · cites it directly · 0 of its ownK082637 Cranial PerforatorThe Anspach Effort, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K231403evoDrill Cranial PerforatorEvonos GmbH & Co. KG · 2024 · cites it directly2descendants
- 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
- K121253Meridian Cranial PerforatorAdeor Medical Technologies GmbH · 2012 · cites it directly0descendants
- K082637Cranial PerforatorThe Anspach Effort, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K791101 | Disposable Perforators, Jacobs, Hudson | Codman & Shurtleff, Inc. | 1979 | — |
| 0 (this device) | K933894 | Disposable Perforator | Codman & Shurtleff, Inc. | 1993 | — |
| +1 | K231403 | evoDrill Cranial Perforator | Evonos GmbH & Co. KG | 2024 | — |
| +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 | K121253 | Meridian Cranial Perforator | Adeor Medical Technologies GmbH | 2012 | — |
| +1 | K082637 | Cranial Perforator | The Anspach Effort, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2024 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K791101 | Disposable Perforators, Jacobs, HudsonSummary page 1…Perforator is designed to be used with a pneumatic or electric drill. The CODMAN Disposable Perforator is substantially equivalent to the Codman Disposable Perforator (K791101A), presently marketed by Codman & Shurtleff, Inc., and the Acra-Cut Disposable Perforator (K833266) marketed by Acra-Cut, Inc., A… | 1979 |
| * | K833266 | Acra-CutSummary page 1…rator is substantially equivalent to the Codman Disposable Perforator (K791101A), presently marketed by Codman & Shurtleff, Inc., and the Acra-Cut Disposable Perforator (K833266) marketed by Acra-Cut, Inc., Acton , MA. Test results show that the strength of the shelf left by the outer drill of the Disposa… | 1983 |
What descends from it? (5)
3 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?
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 | — |
What is it indicated for?
The CODMAN Disposable Perforator, model number 170640-002, is used to perforate the cranium. These perforations may be required to vent fluid from the cranium, to provide access for surgical instruments, or to provide access for tools used to remove a large skull piece.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K933894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933894: Disposable Perforator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933894
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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