510(k) · Cleared
ClearedDoro Radiolucent Headrest System ( Also Mri-Compatible) and Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pro-Med Instruments GmbH · HBL Holder, Head, Neurosurgical (Skull Clamp)
Cleared on May 21, 2007 as substantially equivalent to K032331 (Pro-Med Instruments GmbH, 2003) and 3 other predicates after a 182-day review. Its family tree reaches back 8 generations to 1995. 1 of the 55 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- May 21, 2007
- Review
- 182 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K944964 (1995). 47 ancestors in all, the oldest K871863 (1987). 7 later devices descend from it, 4 citing it directly. 1 of the 55 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 7 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 6 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 5 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 4 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 3 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 2 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- 1 generation backK051501 ZiraceAcucera, Inc. · 2005
- This deviceK063494 Doro Radiolucent Headrest System ( Also Mri-Compatible) and ComponentsPro-Med Instruments GmbH · 2007
- 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 ownK103493 Head Fiation Device (HFD 100)Imris, Inc. · 2011 · Recalled
- Descendant · cites it directly · 1 of its ownK191740 DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH · 2020
- Descendant · 2 generations on · 0 of its ownK250423 mb-FIX Cranial Stabilization SystemsMedical Bees GmbH · 2025
- Descendant · 2 generations on · 0 of its ownK240319 DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp…Pro Med Instruments GmbH · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K032331 Doro Radiolucent Headrest System and Horseshoe…direct predicate · 2003
Most influential descendants
Showing 5 of 7 · See all- K072208Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation · 2007 · cites it directly4descendants
- K103493Head Fiation Device (HFD 100)Imris, Inc. · 2011 · cites it directly2descendants
- K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH · 2020 · cites it directly1descendant
- K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH · 2025 · 2 generations on0descendants
- K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)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 |
|---|---|---|---|---|---|
| −8 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −7 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −5 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −4 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −3 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −2 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| −1 | K051501 | Zirace | Acucera, Inc. | 2005 | — |
| 0 (this device) | K063494 | Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components | Pro-Med Instruments GmbH | 2007 | — |
| +1 | K072208 | Mayfield Disposable and Reusable Titanium Skull Pins | Integra LifeSciences Corporation | 2007 | — |
| +1 | K103493 | Head Fiation Device (HFD 100) | Imris, Inc. | 2011 | 3 |
| +1 | K191740 | DORO LUCENT® iXI and iMRI Headrest System | Pro Med Instruments GmbH | 2020 | — |
| +2 | K250423 | mb-FIX Cranial Stabilization Systems | Medical Bees GmbH | 2025 | — |
| +2 | K240319 | DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set… | Pro Med Instruments GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 8 | 0 |
| 1994 | 8 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
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? (4)
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 |
|---|---|---|---|
| * | K032331 | Doro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent J-Arm…Summary page 2…- Predicate Devices Applicant Product Clearance Number pro med instruments DOROR Radiolucent / MRI K032331, K001808 GmbH Compatible Skull Clamp Headrest System, including Disposable… | 2003 |
| * | K001808 | Doro Headrest SystemSummary page 2…ate Devices Applicant Product Clearance Number pro med instruments DOROR Radiolucent / MRI K032331, K001808 GmbH Compatible Skull Clamp Headrest System, including Disposable Acu… | 2000 |
| * | K051501 | ZiraceSummary page 2…le Skull Clamp Headrest System, including Disposable Acucera, Inc. Skull Pins K051501xc pro med instruments DORO ® Radiolucent/MRI K032331, K001808 GmbH Compatible Horse… | 2005 |
| * | K953124 | Mayfield Radiolucent 2000 Skull ClampSummary page 5…RO® Headrest System (K001808 and K032331), Ohio Medical Instrument Company, Inc.'s (OHIO medical Instrument Co., Inc.) "MAYFIELD Radiolucent 2000 Skull Clamp" (K953124) with the additional application of MRI-compatibility. 7. Biocompatibility The Radiolucent components of the system are… | 1996 |
| † | K013979 | SC-Acufix Thinline Anterior Cervical Plate System | 2002 |
| † | K970541 | Aesculap Modular Monopolar Electrodes | 1997 |
What descends from it? (7)
4 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 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 7 of the 47 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K072208 (Integra LifeSciences Corporation, 2007) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K032331.
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. 2007, 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 Radiolucent / MRI Compatible Skull Clamp Headrest System with Skull Pins The DORO® Radiolucent / MRI Compatible Skull Clamp Headrest System with Skull Pins are components of a mechanical support system which is used in head and neck surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative CT or MR Imaging is used. The Radiolucent / MRI Compatible Horseshoe Headrest System The DORO® Radiolucent / MRI…
Read the full statement (156 words)
The Radiolucent / MRI Compatible Skull Clamp Headrest System with Skull Pins
The DORO® Radiolucent / MRI Compatible Skull Clamp Headrest System with Skull Pins are components of a mechanical support system which is used in head and neck surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative CT or MR Imaging is used.
The Radiolucent / MRI Compatible Horseshoe Headrest System
The DORO® Radiolucent / MRI Compatible Horseshoe Headrest System are components of a mechanical support system which is used in head and neck surgery when non-invasive head support is required and when intra-operative CT or MR Imaging is used.
The Radiolucent / MRI Compatible Halo System
The DORO® Radiolucent / MRI Compatible Halo System is a system of radiolucent halo rings of varying size and styles that may be used in neurosurgical applications as an arm rest during head and neck surgery when intra-operative CT or MR Imaging is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063494 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063494: Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063494
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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