510(k) · Cleared
ClearedMayfield Child 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 Dec 6, 1995 after a 615-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.
- Decided
- Dec 6, 1995
- Review
- 615 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK941558 Mayfield Child Disposable Skull PinOhio Medical Instrument Co., Inc. · 1995
- Descendant · cites it directly · 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 ownK241883 DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs)…Pro Med Instruments GmbH · 2024
Most influential descendants
Showing 2 of 2 · See all- K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull…Pro Med Instruments GmbH · 2020 · cites it directly1descendant
- K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO…Pro Med Instruments GmbH · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941558 | Mayfield Child Disposable Skull Pin | Ohio Medical Instrument Co., Inc. | 1995 | — |
| +1 | K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable… | Pro Med Instruments GmbH | 2020 | — |
| +2 | K241883 | DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00)… | Pro Med Instruments GmbH | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull… | 2020 | 1 |
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, K193438 (Pro Med Instruments GmbH, 2020) has gone furthest, with 1 descendant 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/K941558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941558: Mayfield Child Disposable Skull Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941558
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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