510(k) · Cleared
ClearedTitanium Hemostatic Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitalitec Int'L., Inc. · FZP Clip, Implantable
Cleared on Oct 13, 1998 as substantially equivalent to K972745 (Eisner USA, Inc., 1997) and 4 other predicates after a 158-day review. Its family tree reaches back 2 generations to 1977. 3 later devices descend from it.
- Decided
- Oct 13, 1998
- Review
- 158 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K771021 (1977). 5 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK771021 Auto-ClipAxiom Medical, Inc. · 1977
- 1 generation backK972745 Titanium Hemostatic ClipEisner USA, Inc. · 1997
- This deviceK981645 Titanium Hemostatic ClipVitalitec Int'L., Inc. · 1998
- Descendant · cites it directly · 0 of its ownK242541 Gem ZipclipSynovis Micro Companies Alliance A Subsidiary of Baxter Int · 2025
- Descendant · cites it directly · 0 of its ownK192711 Dannik Titanium Ligation ClipDannik · 2019
- Descendant · cites it directly · 0 of its ownK040602 Sureline Laparoscopic Clip Applier with Implantable Titanium ClipsDesign Standards Corp. · 2004
Most influential descendants
Showing 3 of 3 · See all- K242541Gem ZipclipSynovis Micro Companies Alliance A Subsidiary of Baxter Int · 2025 · cites it directly0descendants
- K192711Dannik Titanium Ligation ClipDannik · 2019 · cites it directly0descendants
- K040602Sureline Laparoscopic Clip Applier with Implantable Titanium ClipsDesign Standards Corp. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771021 | Auto-Clip | Axiom Medical, Inc. | 1977 | — |
| −1 | K972745 | Titanium Hemostatic Clip | Eisner USA, Inc. | 1997 | — |
| 0 (this device) | K981645 | Titanium Hemostatic Clip | Vitalitec Int'L., Inc. | 1998 | — |
| +1 | K242541 | Gem Zipclip | Synovis Micro Companies Alliance A Subsidiary of Baxter Int | 2025 | — |
| +1 | K192711 | Dannik Titanium Ligation Clip | Dannik | 2019 | — |
| +1 | K040602 | Sureline Laparoscopic Clip Applier with Implantable Titanium Clips | Design Standards Corp. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K972745 | Titanium Hemostatic ClipSummary page 1…national Organization Standard , ISO 5832-2-93 “Implants for Surgery - Metallic Materials -Part 2: Unalloyed Titanium”. Predicate Devices: EISNER USA Titanium Hemoclip K972745, Baxter Healthcare Vitaclip ® K953258; Edward Weck & Company, Pre-Amendment Hemoclip ® Surgical Occluding System and Hemoclip® Su… | 1997 |
| * | K953258 | Titanium Hemostatic ClipSummary page 1…832-2-93 “Implants for Surgery - Metallic Materials -Part 2: Unalloyed Titanium”. Predicate Devices: EISNER USA Titanium Hemoclip K972745, Baxter Healthcare Vitaclip ® K953258; Edward Weck & Company, Pre-Amendment Hemoclip ® Surgical Occluding System and Hemoclip® Surgical Occluding Clip-Stainless Steel… | 1996 |
| * | K800079 | Hemoclip Surgical Occluding ClipSummary page 1…45, Baxter Healthcare Vitaclip ® K953258; Edward Weck & Company, Pre-Amendment Hemoclip ® Surgical Occluding System and Hemoclip® Surgical Occluding Clip-Stainless Steel K800079; United States Surgical Corporation, Auto Suture® Titanium Hemostatic Clip K853650 and Axiom Auto-Clip® K771021. Comparison of T… | 1980 |
| * | K853650 | Auto Suture Titanium Hemostatic ClipSummary page 1…clip ® Surgical Occluding System and Hemoclip® Surgical Occluding Clip-Stainless Steel K800079; United States Surgical Corporation, Auto Suture® Titanium Hemostatic Clip K853650 and Axiom Auto-Clip® K771021. Comparison of Technological Characteristics: The titanium clip-material is identical to the predic… | 1985 |
| * | K771021 | Auto-ClipSummary page 1…tem and Hemoclip® Surgical Occluding Clip-Stainless Steel K800079; United States Surgical Corporation, Auto Suture® Titanium Hemostatic Clip K853650 and Axiom Auto-Clip® K771021. Comparison of Technological Characteristics: The titanium clip-material is identical to the predicate devices. In function, the… | 1977 |
What descends from it? (3)
3 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 21 years and passes through 3 companies; a new generation was cleared every 20.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K242541 (Synovis Micro Companies Alliance A Subsidiary of Baxter Int, 2025) 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.
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 VITALITEC INTERNATIONAL, INC,. Hemostatic Clip is designed for the intended use of ligating blood vessels. The clip has been specially designed to insure occclusion 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 VITALITEC INTERNATIONAL, INC., clip can be left in vivo without sequela as it is biologically inert.
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/K981645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981645: Titanium Hemostatic Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981645
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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