510(k) · Cleared
ClearedPsi Titanium Aneurysm Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
V. Mueller Neuro/Spine · HCH Clip, Aneurysm
Cleared on Jan 6, 2000 as substantially equivalent to K983758 (Aesculap, Inc., 1998) and 1 other predicate after a 210-day review. Its family tree reaches back 3 generations to 1977. 1 later device descends from it.
- Decided
- Jan 6, 2000
- Review
- 210 days
- Class
- Class II
- Product code
- HCH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K772200 (1977). 10 ancestors in all, the oldest K760771 (1976). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK772200 Yasargil Aneurysm ClipsAesculap Instruments Corp. · 1977
- 2 generations backK955064 Spetzler TI 100 Aneurysm ClipElekta Instruments, Inc. · 1996
- 1 generation backK983758 Yasargil Titanium Aneurysm ClipsAesculap, Inc. · 1998
- This deviceK991959 Psi Titanium Aneurysm ClipV. Mueller Neuro/Spine · 2000
- Descendant · cites it directly · 0 of its ownK031468 Temporary Titanium Aneurysm ClipCardinalhealth · 2003
Most influential descendants
Showing 1 of 1 · See all- K031468Temporary Titanium Aneurysm ClipCardinalhealth · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K772200 | Yasargil Aneurysm Clips | Aesculap Instruments Corp. | 1977 | — |
| −2 | K955064 | Spetzler TI 100 Aneurysm Clip | Elekta Instruments, Inc. | 1996 | — |
| −1 | K983758 | Yasargil Titanium Aneurysm Clips | Aesculap, Inc. | 1998 | — |
| 0 (this device) | K991959 | Psi Titanium Aneurysm Clip | V. Mueller Neuro/Spine | 2000 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K983758 | Yasargil Titanium Aneurysm ClipsSummary page 1…ohnston, President 650-802-6988 650-802-0120 April 15, 1999 PSI Titanium Aneurysm Clip Aneurysm Clip Aneurysm Clip, 21 CFR 882.5200 Aesculap Titanium Aneurysm Clip (K983758) Taka Aneurysm Clip (K972750) Bent titanium wire which provides a spring operated, self Closing aneurysm clip of various lengths… | 1998 |
| * | K972750 | Taka Aneurysm ClipSummary page 1…88 650-802-0120 April 15, 1999 PSI Titanium Aneurysm Clip Aneurysm Clip Aneurysm Clip, 21 CFR 882.5200 Aesculap Titanium Aneurysm Clip (K983758) Taka Aneurysm Clip (K972750) Bent titanium wire which provides a spring operated, self Closing aneurysm clip of various lengths/sizes. Placement in the int… | 1998 |
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 |
|---|---|---|---|
| K031468 | Temporary Titanium Aneurysm Clip | 2003 | 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 23 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K031468 (Cardinalhealth, 2003) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K983758.
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?
Permanent placement in the brain for occlusion of cerebral aneurysms. They are only to be applied with PSI clip appliers with titanium alloy jaw inserts
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/K991959 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991959: Psi Titanium Aneurysm Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991959
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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