510(k) · Cleared
ClearedHemoclip Ligating Clips Med/SML
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edward Weck, Inc. · FZP Clip, Implantable
Cleared on Aug 14, 1984 after a 120-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Aug 14, 1984
- Review
- 120 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK841547 Hemoclip Ligating Clips Med/SMLEdward Weck, Inc. · 1984
- Descendant · cites it directly · 1 of its ownK132658 Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips…Teleflex Medical · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK192711 Dannik Titanium Ligation ClipDannik · 2019
- Descendant · cites it directly · 0 of its ownK091060 Vesocclude Ligating ClipVesocclude Medical, LLC · 2009
Most influential descendants
Showing 3 of 3 · See all- K132658Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, Horizon Ligting ClipsTeleflex Medical · 2013 · cites it directly1descendant
- K192711Dannik Titanium Ligation ClipDannik · 2019 · 2 generations on0descendants
- K091060Vesocclude Ligating ClipVesocclude Medical, LLC · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K841547 | Hemoclip Ligating Clips Med/SML | Edward Weck, Inc. | 1984 | — |
| +1 | K132658 | Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, Horizon… | Teleflex Medical | 2013 | 1 |
| +2 | K192711 | Dannik Titanium Ligation Clip | Dannik | 2019 | — |
| +1 | K091060 | Vesocclude Ligating Clip | Vesocclude Medical, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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?
- Of its descendants, K132658 (Teleflex Medical, 2013) has gone furthest, with 1 descendant 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.
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 | — |
https://510kreport.com/device/K841547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K841547: Hemoclip Ligating Clips Med/SML.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K841547
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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