510(k) · Cleared
ClearedMayfield Radiolucent 2000 Skull Clamp
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 Feb 9, 1996 after a 219-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 12 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it.
- Decided
- Feb 9, 1996
- Review
- 219 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- This deviceK953124 Mayfield Radiolucent 2000 Skull ClampOhio Medical Instrument Co., Inc. · 1996
- Descendant · cites it directly · 10 of its ownK032331 Doro Radiolucent Headrest System and Horseshoe Headrests,and…Pro-Med Instruments GmbH · 2003 · Recalled (Class I)
- Descendant · cites it directly · 7 of its ownK063494 Doro Radiolucent Headrest System ( Also Mri-Compatible) and ComponentsPro-Med Instruments GmbH · 2007
- Descendant · 2 generations on · 4 of its ownK072208 Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation · 2007
- Descendant · 2 generations on · 2 of its ownK103493 Head Fiation Device (HFD 100)Imris, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK191740 DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K032331 Doro Radiolucent Headrest System and Horseshoe…cites it directly · 2003
Most influential descendants
Showing 5 of 11 · See all- K032331Doro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent J-Arm…Pro-Med Instruments GmbH · 2003 · cites it directly10descendants
- K063494Doro Radiolucent Headrest System ( Also Mri-Compatible) and ComponentsPro-Med Instruments GmbH · 2007 · cites it directly7descendants
- K072208Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation · 2007 · 2 generations on4descendants
- K103493Head Fiation Device (HFD 100)Imris, Inc. · 2011 · 2 generations on2descendants
- K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953124 | Mayfield Radiolucent 2000 Skull Clamp | Ohio Medical Instrument Co., Inc. | 1996 | — |
| +1 | K032331 | Doro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent… | Pro-Med Instruments GmbH | 2003 | Class I |
| +1 | K063494 | Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components | Pro-Med Instruments GmbH | 2007 | — |
| +2 | K072208 | Mayfield Disposable and Reusable Titanium Skull Pins | Integra LifeSciences Corporation | 2007 | — |
| +2 | K103493 | Head Fiation Device (HFD 100) | Imris, Inc. | 2011 | 3 |
| +2 | K191740 | DORO LUCENT® iXI and iMRI Headrest System | Pro Med Instruments GmbH | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 1 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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.
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 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 112 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.
- K032331Doro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent J-Arm Retractor System…Pro-Med Instruments GmbH · 2003 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- Of its descendants, K032331 (Pro-Med Instruments GmbH, 2003) has gone furthest, with 10 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/K953124 · printed Nov 5, 2026
Cite this page
510(k) Report. “K953124: Mayfield Radiolucent 2000 Skull Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K953124
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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