510(k) · Cleared
ClearedDisposable Perforators, Jacobs, Hudson
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 Aug 28, 1979 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 11 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- Aug 28, 1979
- Review
- 76 days
- Class
- Class II
- Product code
- HBF
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 4 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- This deviceK791101 Disposable Perforators, Jacobs, HudsonCodman & Shurtleff, Inc. · 1979
- Descendant · cites it directly · 5 of its ownK071931 Codman Disposable Perforator, Model (S) 26-1222, 26-1223Codman & Shurtleff, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK933894 Disposable PerforatorCodman & Shurtleff, Inc. · 1993
- Descendant · 2 generations on · 2 of its ownK231403 evoDrill Cranial PerforatorEvonos GmbH & Co. KG · 2024
- Descendant · 2 generations on · 1 of its ownK082010 Stryker Disposable Cranial Perforator BitStryker Ireland Ltd., Instruments Division · 2008 · Recalled
- Descendant · 3 generations on · 0 of its ownK254174 Surgical Power SystemGuizhou Zirui Technology Co., Ltd. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K183581 Codman Disposable Perforatorscites it directly · 2019
Most influential descendants
Showing 5 of 10 · See all- K071931Codman Disposable Perforator, Model (S) 26-1222, 26-1223Codman & Shurtleff, Inc. · 2007 · cites it directly5descendants
- K933894Disposable PerforatorCodman & Shurtleff, Inc. · 1993 · cites it directly5descendants
- K231403evoDrill Cranial PerforatorEvonos GmbH & Co. KG · 2024 · 2 generations on2descendants
- K082010Stryker Disposable Cranial Perforator BitStryker Ireland Ltd., Instruments Division · 2008 · 2 generations on1descendant
- K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K791101 | Disposable Perforators, Jacobs, Hudson | Codman & Shurtleff, Inc. | 1979 | — |
| +1 | K071931 | Codman Disposable Perforator, Model (S) 26-1222, 26-1223 | Codman & Shurtleff, Inc. | 2007 | — |
| +1 | K933894 | Disposable Perforator | Codman & Shurtleff, Inc. | 1993 | — |
| +2 | K231403 | evoDrill Cranial Perforator | Evonos GmbH & Co. KG | 2024 | — |
| +2 | K082010 | Stryker Disposable Cranial Perforator Bit | Stryker Ireland Ltd., Instruments Division | 2008 | 1 |
| +3 | K254174 | Surgical Power System | Guizhou Zirui Technology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 1 |
| 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
4 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?
- Of its descendants, K071931 (Codman & Shurtleff, Inc., 2007) has gone furthest, with 5 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/K791101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K791101: Disposable Perforators, Jacobs, Hudson.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K791101
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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