510(k) · Cleared
ClearedDisposable Polymer Ligation Clips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Kangji Medical Instrument Co., Ltd. · FZP Clip, Implantable
Cleared on Nov 20, 2025 as substantially equivalent to K993157 (Weck Closure Systems, 1999) and 1 other predicate after a 261-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Nov 20, 2025
- Review
- 261 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K021808 (2002). 7 ancestors in all, the oldest K922186 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK021808 Weck Hem-O-Lok Automatic Ligating Clip ApplierWeck · 2002 · Recalled
- 3 generations backK142777 Weck Hem-o-lok Auto Endo5 Ligating Clip ApplierTeleflexmedical, Inc. · 2014 · Recalled
- 2 generations backK152081 Weck Auto Endo5 Hem-o-lok Ligating Clip ApplierTeleflexmedical, Inc. · 2015 · Recalled
- 1 generation backK230480 Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)Teleflex Medical · 2023
- This deviceK250643 Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K021808 | Weck Hem-O-Lok Automatic Ligating Clip Applier | Weck | 2002 | 7 |
| −3 | K142777 | Weck Hem-o-lok Auto Endo5 Ligating Clip Applier | Teleflexmedical, Inc. | 2014 | 1 |
| −2 | K152081 | Weck Auto Endo5 Hem-o-lok Ligating Clip Applier | Teleflexmedical, Inc. | 2015 | 1 |
| −1 | K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) | Teleflex Medical | 2023 | — |
| 0 (this device) | K250643 | Disposable Polymer Ligation Clips | Hangzhou Kangji Medical Instrument Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 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 |
|---|---|---|---|
| * | K993157 | Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model 544240Summary page 6…Manufacturer 510(k) No. device Weck Closure Polymer Clips Hem-O-Lok® ligation clips K993157 Systems Weck Auto Endo5® 5mm Multiple Automatic Endoscopic… | 1999 |
| * | K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)Summary page 6…Weck Auto Endo5® 5mm Multiple Automatic Endoscopic 35cm Teleflex Medical K230480 Polymer Clips Applier (Hem-o-lok® ligating Incorporated clips) Table 1 compares the model-Polymer clips to t… | 2023 |
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 23 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 5 of the 7 ancestors have a recall of any class.
- 3 other devices also cite its predicate K993157.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Disposable Polymer Ligation Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250643: Disposable Polymer Ligation Clips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250643
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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