510(k) · Cleared
ClearedSundt Slim-Line Aneurysm Clip Applier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Professionals, Inc. · HCI Applier, Aneurysm Clip
Cleared on Dec 18, 1998 as substantially equivalent to K791764 (Codman & Shurtleff, Inc., 1979) and 1 other predicate after a 163-day review. Its family tree reaches back 1 generation to 1979. 1 later device descends from it.
- Decided
- Dec 18, 1998
- Review
- 163 days
- Class
- Class II
- Product code
- HCI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K791978 (1979). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK791978 Sugita Aneurysm Clips, Appliers & CaseCodman & Shurtleff, Inc. · 1979
- This deviceK982379 Sundt Slim-Line Aneurysm Clip ApplierJohnson & Johnson Professionals, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK994191 Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754…Nmt Medical, Inc. · 2000
Most influential descendants
Showing 1 of 1 · See all- K994191Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754TNmt Medical, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K791978 | Sugita Aneurysm Clips, Appliers & Case | Codman & Shurtleff, Inc. | 1979 | — |
| 0 (this device) | K982379 | Sundt Slim-Line Aneurysm Clip Applier | Johnson & Johnson Professionals, Inc. | 1998 | — |
| +1 | K994191 | Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754T | Nmt Medical, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (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 |
|---|---|---|---|
| * | K791764 | Scoville-Lewis Aneurysm ClipsSummary page 1…t Slim-Line Aneurysm Clip Applier was based on a detailed device description, intended use, materials, design, sterilization, and packaging to the Aneurysm Clip Applier (K791764A) and the Sugita Aneurysm Clip Applier (K791978). *’, mm':.,_" %, ‘Q'"m & %, . s'.': __/@ DEPARTMENT OF HEALTH… | 1979 |
| * | K791978 | Sugita Aneurysm Clips, Appliers & CaseSummary page 1…detailed device description, intended use, materials, design, sterilization, and packaging to the Aneurysm Clip Applier (K791764A) and the Sugita Aneurysm Clip Applier (K791978). *’, mm':.,_" %, ‘Q'"m & %, . s'.': __/@ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service % Food a… | 1979 |
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 |
|---|---|---|---|
| K994191 | Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754T | 2000 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K994191 (Nmt Medical, Inc., 2000) has gone furthest, with 0 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 | — |
What is it indicated for?
The Sundt Slim-Line Aneurysm Clip Applier is designed for use only with Sundt Slim-Line Aneurysm Clips.
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/K982379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982379: Sundt Slim-Line Aneurysm Clip Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982379
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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