510(k) · Cleared
ClearedMayfield MR/X-Ray Skull Clamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Corp. · HBL Holder, Head, Neurosurgical (Skull Clamp)
Cleared on Oct 8, 2008 as substantially equivalent to K050319 (Integra Lifesciences Corp., 2005) after a 142-day review. Its family tree reaches back 1 generation to 2005. 3 later devices descend from it.
- Decided
- Oct 8, 2008
- Review
- 142 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050319 (2005). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK050319 Mayfield MR/CT Skull Clamp, Model 4-0-a-1104Integra Lifesciences Corp. · 2005
- This deviceK081401 Mayfield MR/X-Ray Skull ClampIntegra Lifesciences Corp. · 2008
- Descendant · cites it directly · 2 of its ownK103493 Head Fiation Device (HFD 100)Imris, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK141950 HFD100 Rocker Arm AccessoryImris, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK113748 Imris MR/X-Ray Head Fixation Device (HFD)Imris, Inc. · 2012 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050319 | Mayfield MR/CT Skull Clamp, Model 4-0-a-1104 | Integra Lifesciences Corp. | 2005 | — |
| 0 (this device) | K081401 | Mayfield MR/X-Ray Skull Clamp | Integra Lifesciences Corp. | 2008 | — |
| +1 | K103493 | Head Fiation Device (HFD 100) | Imris, Inc. | 2011 | 3 |
| +2 | K141950 | HFD100 Rocker Arm Accessory | Imris, Inc. | 2014 | — |
| +1 | K113748 | Imris MR/X-Ray Head Fixation Device (HFD) | Imris, Inc. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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 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? (1)
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 |
|---|---|---|---|
| * | K050319 | Mayfield MR/CT Skull Clamp, Model 4-0-a-1104Summary page 1…equivalent in function and intended use to the unmodified MAYFIELD® MR/CT Skull Clamp which has been cleared to market under Premarket Notification 510(k) K050319. Indications Use: The MAYFIELD® MR/X-Ray Skull clamp is placed on the patient's skull to hold their head and nec… | 2005 |
What descends from it? (3)
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?
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. 2008, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The MAYFIELD® MR/X-Ray Skull clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. In addition, the clamp is indicated for use during utilization of imaging modalities such as intraoperative CT and MR imaging, C-Arm X-ray, and digital subtraction techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081401 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081401: Mayfield MR/X-Ray Skull Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081401
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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