510(k) · Cleared
ClearedCranial Perforator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Anspach Effort, Inc. · HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)
Cleared on Dec 22, 2008 as substantially equivalent to K982991 (The Anspach Effort, Inc., 1998) and 5 other predicates after a 103-day review. Its family tree reaches back 2 generations to 1979.
- Decided
- Dec 22, 2008
- Review
- 103 days
- Class
- Class II
- Product code
- HBF
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K791101 (1979). 6 ancestors in all. No later device cites it as a predicate yet.
View 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) | K082637 | Cranial Perforator | The Anspach Effort, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1989 | 1 | 0 |
| 1998 | 1 | 0 |
| 2007 | 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
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K982991 | Anspach Access Cranial PerforatorSummary page 1…Class 1I Classification Neurology Devices Panel 21 CFR § 882.4305 Predicate Anspach Access Cranial Perforator -> K982991 Devices Codman & Shurtleff, Inc. Disposable Perforator -> K933 894, K07 193 1 and D… | 1998 |
| * | K933894 | Disposable PerforatorSummary page 1…ate Anspach Access Cranial Perforator -> K982991 Devices Codman & Shurtleff, Inc. Disposable Perforator -> K933 894, K07 193 1 and Disposable Perforators Jacobs, Hudson -> K791 101 Acra Cut,… | 1993 |
| * | K071931 | Codman Disposable Perforator, Model (S) 26-1222, 26-1223Summary page 1…Anspach Access Cranial Perforator -> K982991 Devices Codman & Shurtleff, Inc. Disposable Perforator -> K933 894, K07 193 1 and Disposable Perforators Jacobs, Hudson -> K791 101 Acra Cut, Inc. Automa… | 2007 |
| * | K791101 | Disposable Perforators, Jacobs, HudsonSummary page 1…Codman & Shurtleff, Inc. Disposable Perforator -> K933 894, K07 193 1 and Disposable Perforators Jacobs, Hudson -> K791 101 Acra Cut, Inc. Automatic Cranial Drill (Perforator) - K892866 and Acra Cut,… | 1979 |
| * | K892866 | Automatic Cranial Drill (Perforator)Summary page 1…orators Jacobs, Hudson -> K791 101 Acra Cut, Inc. Automatic Cranial Drill (Perforator) - K892866 and Acra Cut, Inc. -> K833266 Performance Performance standards have not been established by the… | 1989 |
| * | K833266 | Acra-CutSummary page 1…Hudson -> K791 101 Acra Cut, Inc. Automatic Cranial Drill (Perforator) - K892866 and Acra Cut, Inc. -> K833266 Performance Performance standards have not been established by the FDA under Section… | 1983 |
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 29 years and passes through 2 companies; a new generation was cleared every 15.0 years on median.
- None of the 6 ancestors has a recall.
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. 2008, 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 Cranial Perforator is a sterile, single use cutting device intended for performing cranial trephination in bone at least 3 mm thick (i.e., adult skulls).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082637 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082637: Cranial Perforator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082637
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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