510(k) · Cleared
Recalled · Class I · 2018Doro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent J-Arm Retractor System (Aluminum Alloy)
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 Nov 20, 2003 as substantially equivalent to K001808 (Pro-Med Instruments GmbH, 2000) and 2 other predicates after a 114-day review. Its family tree reaches back 1 generation to 1991. 1 of the 14 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled 3 times, including 3 Class I recalls.
- Decided
- Nov 20, 2003
- Review
- 114 days
- Class
- Class II
- Product code
- HBL
- Recalls
- 3 (3 Class I)
- Predicates
- 3
Its longest line of descent runs back 1 generation to K913233 (1991). 3 ancestors in all. 10 later devices descend from it, 3 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK913233 Codman Lhalo Split Ring Retractor SystemCodman & Shurtleff, Inc. · 1991
- This deviceK032331 Doro Radiolucent Headrest System and Horseshoe Headrests,and…Pro-Med Instruments GmbH · 2003
- 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
- Descendant · 3 generations on · 0 of its ownK250423 mb-FIX Cranial Stabilization SystemsMedical Bees GmbH · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- 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
- K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913233 | Codman Lhalo Split Ring Retractor System | Codman & Shurtleff, Inc. | 1991 | — |
| 0 (this device) | K032331 | Doro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent… | Pro-Med Instruments GmbH | 2003 | — |
| +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 | — |
| +3 | K250423 | mb-FIX Cranial Stabilization Systems | Medical Bees GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (3)
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 |
|---|---|---|---|
| * | K001808 | Doro Headrest SystemSummary page 2…Director A1-2 2. Name af Predicate Devices Product Clearance Number pro med instruments K 001808 GMBH DOROB Headrest System, Skull Pins and Halo Retractor System OM1 MAYFIELD K 953 124 Radiolucent 2000 Skull Clamp J… | 2000 |
| * | K953124 | Mayfield Radiolucent 2000 Skull ClampSummary page 2…evices Product Clearance Number pro med instruments K 001808 GMBH DOROB Headrest System, Skull Pins and Halo Retractor System OM1 MAYFIELD K 953 124 Radiolucent 2000 Skull Clamp J&J (CODMAN) Halo (K913233) Split Ring Retractor System Materials Spinal Concepts, Inc.… | 1996 |
| * | K913233 | Codman Lhalo Split Ring Retractor SystemSummary page 2…uments K 001808 GMBH DOROB Headrest System, Skull Pins and Halo Retractor System OM1 MAYFIELD K 953 124 Radiolucent 2000 Skull Clamp J&J (CODMAN) Halo (K913233) Split Ring Retractor System Materials Spinal Concepts, Inc. SC- KO 13979 (Laminate( lllien phenolic composite) Acuflx Thinl… | 1991 |
| † | K013979 | SC-Acufix Thinline Anterior Cervical Plate System | 2002 |
| † | K970541 | Aesculap Modular Monopolar Electrodes | 1997 |
What descends from it? (10)
3 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 |
|---|---|---|---|---|
| Jul 5, 2018 | Class I | Z-2971-2018 | Component change control | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system. |
| Jul 5, 2018 | Class I | Z-2970-2018 | Component change control | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system. |
| Jul 5, 2018 | Class I | Z-2972-2018 | Component change control | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system. |
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.
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 DORO Radiolucent Headrest System is used in open and percutaneous craniotomies and spinal surgeries for rigid cranial fixation and when intraoperative CT imaging is used.
The DOROO J-ARM Retractor Accessory is used to fix tissue retractor during neurosurgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032331: Doro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent J-Arm Retractor System (Aluminum Alloy).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032331
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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