510(k) · Cleared
ClearedDORO QR3 Headrest System (Aluminum)
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 Mar 29, 2021 as substantially equivalent to K032331 (Pro-Med Instruments GmbH, 2003) after a 119-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
- Mar 29, 2021
- Review
- 119 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 deviceK203505 DORO QR3 Headrest System (Aluminum)Pro Med Instruments GmbH · 2021
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) | K203505 | DORO QR3 Headrest System (Aluminum) | Pro Med Instruments GmbH | 2021 | — |
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…DORO RADIOLUCENT HEADREST SYSTEM DORO® QR3 Headrest AND HORSESHOE HEADRESTS,AND NON- K032331 Pro med instruments GmbH System (Aluminum) RADIOLUCENT J-ARM RETRACTOR SYSTE… | 2003 |
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 30 years and passes through 3 companies; a new generation was cleared every 17.4 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. 2021, 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 Headrest System 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 skeletal fixation is necessary.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203505: DORO QR3 Headrest System (Aluminum).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203505
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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