510(k) · Cleared
ClearedNew Sizes Sugita Clips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Downs Surgical, Ltd. · HCI Applier, Aneurysm Clip
Cleared on Jun 6, 1988 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Jun 6, 1988
- Review
- 28 days
- Class
- Class II
- Product code
- HCI
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK881911 New Sizes Sugita ClipsDowns Surgical, Ltd. · 1988
- Descendant · cites it directly · 13 of its ownK955064 Spetzler TI 100 Aneurysm ClipElekta Instruments, Inc. · 1996
- Descendant · 2 generations on · 8 of its ownK983758 Yasargil Titanium Aneurysm ClipsAesculap, Inc. · 1998
- Descendant · 2 generations on · 6 of its ownK984109 Aesculap Axial Clip ApplierAesculap, Inc. · 1999
- Descendant · 2 generations on · 6 of its ownK970050 Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc. · 1997
- Descendant · 3 generations on · 4 of its ownK131500 Yasargil Aneurysm Clips and Clip AppliersAesculap, Inc. · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K955064Spetzler TI 100 Aneurysm ClipElekta Instruments, Inc. · 1996 · cites it directly13descendants
- K983758Yasargil Titanium Aneurysm ClipsAesculap, Inc. · 1998 · 2 generations on8descendants
- K984109Aesculap Axial Clip ApplierAesculap, Inc. · 1999 · 2 generations on6descendants
- K970050Yasargil Titanium Aneurysm Clips (Ftxxxt)Aesculap, Inc. · 1997 · 2 generations on6descendants
- K131500Yasargil Aneurysm Clips and Clip AppliersAesculap, Inc. · 2014 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K881911 | New Sizes Sugita Clips | Downs Surgical, Ltd. | 1988 | — |
| +1 | K955064 | Spetzler TI 100 Aneurysm Clip | Elekta Instruments, Inc. | 1996 | — |
| +2 | K983758 | Yasargil Titanium Aneurysm Clips | Aesculap, Inc. | 1998 | — |
| +2 | K984109 | Aesculap Axial Clip Applier | Aesculap, Inc. | 1999 | — |
| +2 | K970050 | Yasargil Titanium Aneurysm Clips (Ftxxxt) | Aesculap, Inc. | 1997 | — |
| +3 | K131500 | Yasargil Aneurysm Clips and Clip Appliers | Aesculap, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HCI? 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 HCI device
- #1 K211572 Aesculap Slim Clip Applierscore 7.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K955064 | Spetzler TI 100 Aneurysm Clip | 1996 | 13 |
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?
- Of its descendants, K955064 (Elekta Instruments, Inc., 1996) has gone furthest, with 13 descendants of its own.
How does its category compare?
All HCI devicesHCI Applier, Aneurysm Clip: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCI
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HCI
Too few HCI 510(k)s in any year since 2007 to give a median.
Recalls per year · HCI
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HCI
1in 2025
MAUDE reports naming product code HCI, 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 | 0 | — | 2 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 27 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 6 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K881911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K881911: New Sizes Sugita Clips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881911
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026