510(k) · Cleared
Recalled · Class II · 2025Doro Headrest System
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 Aug 4, 2000 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 13 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 4, 2000
- Review
- 50 days
- Class
- Class II
- Product code
- HBL
- Recalls
- 2
- Predicates
- 0
12 later devices descend from it, 3 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- This deviceK001808 Doro Headrest SystemPro-Med Instruments GmbH · 2000
- 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 12 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 12 · 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) | K001808 | Doro Headrest System | Pro-Med Instruments GmbH | 2000 | — |
| +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 |
| 2010 | 1 | 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? (12)
See all 123 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 14, 2025 | Class II | Z-1860-2025 | Device Design | Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded. |
| Nov 2, 2017 | Class II | Z-0193-2018 | Under Investigation by firm | The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end of the conical part of the skull pin tip. |
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/K001808 · printed Nov 5, 2026
Cite this page
510(k) Report. “K001808: Doro Headrest System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001808
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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