510(k) · Cleared
ClearedTemporary Titanium Aneurysm Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinalhealth · HCH Clip, Aneurysm
Cleared on Jun 20, 2003 as substantially equivalent to K991959 (V. Mueller Neuro/Spine, 2000) after a 42-day review. Its family tree reaches back 4 generations to 1977.
- Decided
- Jun 20, 2003
- Review
- 42 days
- Class
- Class II
- Product code
- HCH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K772200 (1977). 11 ancestors in all, the oldest K760771 (1976). No later device cites it as a predicate yet.
- Root · 4 generations backK772200 Yasargil Aneurysm ClipsAesculap Instruments Corp. · 1977
- 3 generations backK955064 Spetzler TI 100 Aneurysm ClipElekta Instruments, Inc. · 1996
- 2 generations backK983758 Yasargil Titanium Aneurysm ClipsAesculap, Inc. · 1998
- 1 generation backK991959 Psi Titanium Aneurysm ClipV. Mueller Neuro/Spine · 2000
- This deviceK031468 Temporary Titanium Aneurysm ClipCardinalhealth · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K772200 | Yasargil Aneurysm Clips | Aesculap Instruments Corp. | 1977 | — |
| −3 | K955064 | Spetzler TI 100 Aneurysm Clip | Elekta Instruments, Inc. | 1996 | — |
| −2 | K983758 | Yasargil Titanium Aneurysm Clips | Aesculap, Inc. | 1998 | — |
| −1 | K991959 | Psi Titanium Aneurysm Clip | V. Mueller Neuro/Spine | 2000 | — |
| 0 (this device) | K031468 | Temporary Titanium Aneurysm Clip | Cardinalhealth | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1979 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 1998 | 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 HCH? 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 HCH device
- #1 K211183 Sugita AVM Microclipsscore 3.2 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K991959 | Psi Titanium Aneurysm ClipSummary page 1…m Clip Common Name: Aneurysm Clip Classification: Clip, Aneurysm Predicate Device: (K991959) PSI Titanium Aneurysm Clip Description: The temporary… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- None of the 11 ancestors has a recall.
How does its category compare?
All HCH devicesHCH Clip, Aneurysm: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCH
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HCH
Too few HCH 510(k)s in any year since 2007 to give a median.
Recalls per year · HCH
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HCH
2in 2025
MAUDE reports naming product code HCH, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 2 | 3 |
| 2014 | 1 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 1 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Temporary placement in the brain to facilitate occlusion of cerebral aneurysms. Clips are only to be applied with V. Mueller titanium coated clip appliers.
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/K031468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031468: Temporary Titanium Aneurysm Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031468
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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