510(k) · Cleared
ClearedMayfield Adult Disposable Skull Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohio Medical Instrument Co., Inc. · HBL Holder, Head, Neurosurgical (Skull Clamp)
Cleared on Sep 28, 1993 after a 109-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- Sep 28, 1993
- Review
- 109 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK932860 Mayfield Adult Disposable Skull PinOhio Medical Instrument Co., Inc. · 1993
- Descendant · cites it directly · 4 of its ownK072208 Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation · 2007
- Descendant · cites it directly · 2 of its ownK163322 TZ SKULL PIN AdultTz Medical, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK103493 Head Fiation Device (HFD 100)Imris, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK193438 DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile…Pro Med Instruments GmbH · 2020
- Descendant · 2 generations on · 0 of its ownK250423 mb-FIX Cranial Stabilization SystemsMedical Bees GmbH · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K072208Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation · 2007 · cites it directly4descendants
- K163322TZ SKULL PIN AdultTz Medical, Inc. · 2017 · cites it directly2descendants
- K103493Head Fiation Device (HFD 100)Imris, Inc. · 2011 · 2 generations on2descendants
- K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull…Pro Med Instruments GmbH · 2020 · 2 generations on1descendant
- K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932860 | Mayfield Adult Disposable Skull Pin | Ohio Medical Instrument Co., Inc. | 1993 | — |
| +1 | K072208 | Mayfield Disposable and Reusable Titanium Skull Pins | Integra LifeSciences Corporation | 2007 | — |
| +1 | K163322 | TZ SKULL PIN Adult | Tz Medical, Inc. | 2017 | — |
| +2 | K103493 | Head Fiation Device (HFD 100) | Imris, Inc. | 2011 | 3 |
| +2 | K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable… | Pro Med Instruments GmbH | 2020 | — |
| +2 | K250423 | mb-FIX Cranial Stabilization Systems | Medical Bees GmbH | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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.
Planning a device in HBL? 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 HBL device
- #1 K250423 mb-FIX Cranial Stabilization Systemsscore 13.0 · 10 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
2 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?
- Of its descendants, K072208 (Integra LifeSciences Corporation, 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All HBL devicesHBL Holder, Head, Neurosurgical (Skull Clamp): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HBL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBL
54in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HBL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBL
272in 2025
MAUDE reports naming product code HBL, 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 | 3 | 30 | 0 | 39 |
| 2008 | 2 | — | 0 | 103 |
| 2009 | 3 | 54 | 0 | 97 |
| 2010 | 1 | — | 0 | 154 |
| 2011 | 1 | — | 0 | 199 |
| 2012 | 2 | — | 1 | 170 |
| 2013 | 2 | — | 1 | 148 |
| 2014 | 2 | — | 0 | 166 |
| 2015 | 0 | — | 0 | 196 |
| 2016 | 0 | — | 0 | 280 |
| 2017 | 1 | — | 1 | 296 |
| 2018 | 0 | — | 0 | 305 |
| 2019 | 2 | — | 1 | 1,028 |
| 2020 | 2 | — | 1 | 607 |
| 2021 | 1 | — | 0 | 512 |
| 2022 | 0 | — | 1 | 268 |
| 2023 | 0 | — | 0 | 265 |
| 2024 | 2 | — | 0 | 197 |
| 2025 | 1 | — | 1 | 272 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K932860 · printed Nov 5, 2026
Cite this page
510(k) Report. “K932860: Mayfield Adult Disposable Skull Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K932860
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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