510(k) · Cleared
ClearedCodman Disposable Perforator, Model (S) 26-1222, 26-1223
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 Oct 22, 2007 as substantially equivalent to K791101 (Codman & Shurtleff, Inc., 1979) after a 101-day review. Its family tree reaches back 1 generation to 1979. 1 of the 7 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Oct 22, 2007
- Review
- 101 days
- Class
- Class II
- Product code
- HBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K791101 (1979). 5 later devices descend from it, 5 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK791101 Disposable Perforators, Jacobs, HudsonCodman & Shurtleff, Inc. · 1979
- This deviceK071931 Codman Disposable Perforator, Model (S) 26-1222, 26-1223Codman & Shurtleff, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK082010 Stryker Disposable Cranial Perforator BitStryker Ireland Ltd., Instruments Division · 2008 · Recalled
- Descendant · cites it directly · 0 of its ownK183581 Codman Disposable PerforatorsIntegra Lifesciences Corp. · 2019 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK141455 Easydrill Autostop Cranial PerforatorMicromar Ind. Com., Ltd. · 2015
- 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
Class I recalls in this family
- K183581 Codman Disposable Perforatorscites it directly · 2019
Most influential descendants
Showing 5 of 5 · See all- K082010Stryker Disposable Cranial Perforator BitStryker Ireland Ltd., Instruments Division · 2008 · cites it directly1descendant
- K183581Codman Disposable PerforatorsIntegra Lifesciences Corp. · 2019 · cites it directly0descendants
- K141455Easydrill Autostop Cranial PerforatorMicromar Ind. Com., Ltd. · 2015 · cites it directly0descendants
- 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) | K071931 | Codman Disposable Perforator, Model (S) 26-1222, 26-1223 | Codman & Shurtleff, Inc. | 2007 | — |
| +1 | K082010 | Stryker Disposable Cranial Perforator Bit | Stryker Ireland Ltd., Instruments Division | 2008 | 1 |
| +1 | K183581 | Codman Disposable Perforators | Integra Lifesciences Corp. | 2019 | Class I |
| +1 | K141455 | Easydrill Autostop Cranial Perforator | Micromar Ind. Com., Ltd. | 2015 | — |
| +1 | K121253 | Meridian Cranial Perforator | Adeor Medical Technologies GmbH | 2012 | — |
| +1 | K082637 | Cranial Perforator | The Anspach Effort, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K791101 | Disposable Perforators, Jacobs, HudsonSummary page 1…84 HBF). Statement of Substantial Equivalence Codman Disposable Perforators are substantially equivalent to the Codman Disposable Perforator with Hudson End (K791 101A) based on the device's similarity to the predicate device in intended use, materials, design, and principles of oper… | 1979 |
What descends from it? (5)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K183581Codman Disposable PerforatorsIntegra Lifesciences Corp. · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 13 Class I recalls
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. 2007, 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 CODMAN® Disposable Perforators are indicated for perforating the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071931 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071931: Codman Disposable Perforator, Model (S) 26-1222, 26-1223.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071931
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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