510(k) · Cleared
ClearedDORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
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 Jun 2, 2020 as substantially equivalent to K163322 (Tz Medical, Inc., 2017) and 2 other predicates after a 174-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Jun 2, 2020
- Review
- 174 days
- Class
- Class II
- Product code
- HBL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K923789 (1993). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK923789 Mayfield Adult Disposable Skull PinOhio Medical Instrument Co., Inc. · 1993
- 1 generation backK073163 Limited Artifact Skull Pin, Model 0107Dinkler Surgical Devices, Inc. · 2008
- This deviceK193438 DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile…Pro Med Instruments GmbH · 2020
- Descendant · cites it directly · 0 of its ownK241883 DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs)…Pro Med Instruments GmbH · 2024
Most influential descendants
Showing 1 of 1 · See all- K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO…Pro Med Instruments GmbH · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923789 | Mayfield Adult Disposable Skull Pin | Ohio Medical Instrument Co., Inc. | 1993 | — |
| −1 | K073163 | Limited Artifact Skull Pin, Model 0107 | Dinkler Surgical Devices, Inc. | 2008 | — |
| 0 (this device) | K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable… | Pro Med Instruments GmbH | 2020 | — |
| +1 | K241883 | DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00)… | Pro Med Instruments GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
Planning a device in HBL? 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 |
|---|---|---|---|
| * | K163322 | TZ SKULL PIN AdultSummary page 5…ins (Stainless Steel) Model: TZ Skull Pin TZ 1. (3006-00 K163322 Adult Medical, Inc. Stainless Steel, A… | 2017 |
| * | K941558 | Mayfield Child Disposable Skull PinSummary page 5…3. (3006-10 Stainless Steel, Mayfield Child OHIO MEDICAL INSTRUMENT Pediatric, Disposable Skull K941558 CO., INC. Yellow) Pin… | 1995 |
| * | K073163 | Limited Artifact Skull Pin, Model 0107Summary page 6…ice Predicate Device 510(k) 510(k) Holder Number DORO® Sterile Limited Artifact K073163 Dinkier Surgical Devices, Inc. Disposable Skull Pins Skull Pin (Titanium) Model: 1. (3006-20 Titanium,… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241883 | DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO… | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 15.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K241883 (Pro Med Instruments GmbH, 2024) has gone furthest, with 0 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. 2020, 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?
Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193438: DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193438
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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