510(k) · Cleared
ClearedAmsel Occluder Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amsel Medical Corporation · FZP Clip, Implantable
Cleared on Jan 23, 2015 as substantially equivalent to K032238 (Neurosel (Medical) Limited, 2003) and 1 other predicate after a 287-day review. Its family tree reaches back 2 generations to 1983. 2 later devices descend from it.
- Decided
- Jan 23, 2015
- Review
- 287 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K830503 (1983). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK830503 Ligaclip Titanium Ligating ClipETHICON, Inc. · 1983 · Recalled
- 1 generation backK032238 Twister Superelastic Ligating Clip and ApplierNeurosel (Medical) Limited · 2003
- This deviceK140932 Amsel Occluder DeviceAmsel Medical Corporation · 2015
- Descendant · cites it directly · 0 of its ownK260677 Vessel Closure Device (VCD177213P)Vcd Medical S.R.L. · 2026
- Descendant · cites it directly · 0 of its ownK180650 Amsel Endo OccluderAmsel Medical Corporation · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830503 | Ligaclip Titanium Ligating Clip | ETHICON, Inc. | 1983 | 3 |
| −1 | K032238 | Twister Superelastic Ligating Clip and Applier | Neurosel (Medical) Limited | 2003 | — |
| 0 (this device) | K140932 | Amsel Occluder Device | Amsel Medical Corporation | 2015 | — |
| +1 | K260677 | Vessel Closure Device (VCD177213P) | Vcd Medical S.R.L. | 2026 | — |
| +1 | K180650 | Amsel Endo Occluder | Amsel Medical Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2026 | 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 FZP? 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 FZP device
- #1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K032238 | Twister Superelastic Ligating Clip and ApplierSummary page 5…Class II 5.7 Panel General & Plastic Surgery 5.8 Predicate Devices 1. Neurosel Medical Ltd. Twister Superelastic Ligating Clip cleared under K032238, (product code FZP, Regulation No. 878.4300). 2. Ethicon Inc. LigaClip, cleared under K834267 (product code FZP, Regulatio… | 2003 |
| * | K834267 | Ligaclip Metallic Ligating ClipSummary page 5…dical Ltd. Twister Superelastic Ligating Clip cleared under K032238, (product code FZP, Regulation No. 878.4300). 2. Ethicon Inc. LigaClip, cleared under K834267 (product code FZP, Regulation No. 878.4300). 5.9 Intended Use The Amsel Occluder Device is intended for use in… | 1984 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 32 years and passes through 3 companies; a new generation was cleared every 20.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K260677 (Vcd Medical S.R.L., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · FZP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FZP
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FZP
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FZP
1,902in 2025
MAUDE reports naming product code FZP, 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 | 6 | 31 | 1 | 1,877 |
| 2008 | 4 | 23 | 6 | 981 |
| 2009 | 3 | 22 | 0 | 2,160 |
| 2010 | 6 | 47 | 1 | 2,367 |
| 2011 | 3 | 124 | 0 | 1,678 |
| 2012 | 2 | — | 1 | 1,677 |
| 2013 | 3 | 47 | 0 | 2,381 |
| 2014 | 3 | 29 | 1 | 2,320 |
| 2015 | 8 | 182 | 0 | 2,871 |
| 2016 | 5 | 72 | 2 | 1,840 |
| 2017 | 4 | 29 | 1 | 2,594 |
| 2018 | 4 | 143 | 0 | 2,718 |
| 2019 | 1 | — | 3 | 2,903 |
| 2020 | 2 | — | 1 | 1,760 |
| 2021 | 0 | — | 0 | 1,759 |
| 2022 | 3 | 227 | 0 | 1,575 |
| 2023 | 3 | 65 | 0 | 1,918 |
| 2024 | 2 | — | 0 | 2,067 |
| 2025 | 5 | 90 | 0 | 1,902 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Amsel Occluder Device is intended for use in open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140932 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140932: Amsel Occluder Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140932
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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