510(k) · Cleared
ClearedDORO QR3 XTom Headholder 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 Oct 22, 2019 as substantially equivalent to K032331 (Pro-Med Instruments GmbH, 2003) after a 90-day review. Its family tree reaches back 2 generations to 1991. 1 of the 5 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 22, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913233 (1991). 4 ancestors in all. No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK913233 Codman Lhalo Split Ring Retractor SystemCodman & Shurtleff, Inc. · 1991
- 1 generation backK032331 Doro Radiolucent Headrest System and Horseshoe Headrests,and…Pro-Med Instruments GmbH · 2003 · Recalled (Class I)
- This deviceK191979 DORO QR3 XTom Headholder SystemPro Med Instruments GmbH · 2019
Class I recalls in this family
- K032331 Doro Radiolucent Headrest System and Horseshoe…direct predicate · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913233 | Codman Lhalo Split Ring Retractor System | Codman & Shurtleff, Inc. | 1991 | — |
| −1 | K032331 | Doro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent… | Pro-Med Instruments GmbH | 2003 | Class I |
| 0 (this device) | K191979 | DORO QR3 XTom Headholder System | Pro Med Instruments GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 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? (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 |
|---|---|---|---|
| * | K032331 | Doro Radiolucent Headrest System and Horseshoe Headrests,and Non-Radiolucent J-Arm…Summary page 5…Number DO R O® Q R3 XTom DO R O R ADIOLUCENT HEADREST K032331 pro m e d instruments GmbH He adholder System SYSTEM AND C O MPONENTS 4 Reference Device… | 2003 |
| † | K001808 | Doro Headrest System | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 15.9 years on median.
- 2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- 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. 2019, 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 DORO® QR3 XTom Headholder System is a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging with a CT-Scanner is used.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191979 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191979: DORO QR3 XTom Headholder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191979
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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