510(k) · Cleared
Recalled · Class I · 2025Codman Disposable Perforators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Corp. · HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)
Cleared on Jan 20, 2019 as substantially equivalent to K791101 (Codman & Shurtleff, Inc., 1979) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1979. 1 of the 3 devices in its family, counting itself, has a Class I recall. It has been recalled 3 times, including 3 Class I recalls.
- Decided
- Jan 20, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- HBF
- Recalls
- 3 (3 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K791101 (1979). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
View FIG. 1 as a table
Line of descent and top descendants
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? (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 4…Date Cleared Title Codman Disposable Perforator K791101 Aug. 28, 1979 (14mm)… | 1979 |
| * | K071931 | Codman Disposable Perforator, Model (S) 26-1222, 26-1223Summary page 4…(14mm) Codman Disposable Perforators K071931 Oct. 22, 2007 (11mm & 9mm) IV. Device… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2025 | Class I | Z-0373-2026 | Process change control | Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution. |
| Sep 26, 2025 | Class I | Z-0374-2026 | Process change control | Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution. |
| Apr 11, 2025 | Class I | Z-1716-2025 | Process control | Inadequate weld that can potentially cause the product to disassemble. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 40 years and passes through 2 companies; a new generation was cleared every 28.2 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K791101.
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. 2019, 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 Perforator is for use in 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/K183581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183581: Codman Disposable Perforators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183581
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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