510(k) · Cleared
ClearedDannik Titanium Ligation Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dannik · FZP Clip, Implantable
Cleared on Dec 20, 2019 as substantially equivalent to K981645 (Vitalitec Int'L., Inc., 1998) and 1 other predicate after an 84-day review. Its family tree reaches back 3 generations to 1977.
- Decided
- Dec 20, 2019
- Review
- 84 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K771021 (1977). 9 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K771021 | Auto-Clip | Axiom Medical, Inc. | 1977 | — |
| −2 | K972745 | Titanium Hemostatic Clip | Eisner USA, Inc. | 1997 | — |
| −1 | K981645 | Titanium Hemostatic Clip | Vitalitec Int'L., Inc. | 1998 | — |
| 0 (this device) | K192711 | Dannik Titanium Ligation Clip | Dannik | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K981645 | Titanium Hemostatic ClipSummary page 4…• Legally Marketed (unmodified Devices): o Primary Predicate: Vitalitec International Inc Implantable Titanium Hemostatic Clip FDA 510K (K981645) o Additional Predicate: Weck Metal Ligating Clips (K132658)… | 1998 |
| * | K132658 | Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, Horizon Ligting ClipsSummary page 4…ate: Vitalitec International Inc Implantable Titanium Hemostatic Clip FDA 510K (K981645) o Additional Predicate: Weck Metal Ligating Clips (K132658) K192711… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 42 years and passes through 4 companies; a new generation was cleared every 20.4 years on median.
- 3 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K981645.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 DANNIK Titanium Ligation Clips is designed for the intended use of ligating blood vessels .The Clip has been
specially designed to insure occlusion of vessels and prevent any slippage once applied. The clip has applications in many
types of surgical procedures where hemostasis is required or radiographic marking is necessary.
Choose the size of clip to fit the procedure making certain the tissue to be occluded fits completely within the clip. The
DANNIK Titanium Ligation, clip can be left in vivo without sequela as it is biologically inert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192711: Dannik Titanium Ligation Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192711
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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