510(k) · Cleared
Recalled · Class II · 2019Weck Hem-O-Lok Automatic Ligating Clip Applier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Aug 14, 2002 after a 72-day review. The FDA summary names its predicate without a number. 11 later devices descend from it. It has been recalled 7 times.
- Decided
- Aug 14, 2002
- Review
- 72 days
- Class
- Class II
- Product code
- FZP
- Recalls
- 7
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK021808 Weck Hem-O-Lok Automatic Ligating Clip ApplierWeck · 2002
- Descendant · cites it directly · 5 of its ownK142777 Weck Hem-o-lok Auto Endo5 Ligating Clip ApplierTeleflexmedical, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 4 of its ownK152081 Weck Auto Endo5 Hem-o-lok Ligating Clip ApplierTeleflexmedical, Inc. · 2015 · Recalled
- Descendant · cites it directly · 4 of its ownK062914 Hem-O-Lok Ligation ClipTeleflex Medical · 2006
- Descendant · 2 generations on · 3 of its ownK133202 Hem-O-Lok Ligating ClipTeleflex Medical · 2013
- Descendant · 3 generations on · 2 of its ownK230480 Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)Teleflex Medical · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K142777Weck Hem-o-lok Auto Endo5 Ligating Clip ApplierTeleflexmedical, Inc. · 2014 · cites it directly5descendants
- K152081Weck Auto Endo5 Hem-o-lok Ligating Clip ApplierTeleflexmedical, Inc. · 2015 · 2 generations on4descendants
- K062914Hem-O-Lok Ligation ClipTeleflex Medical · 2006 · cites it directly4descendants
- K133202Hem-O-Lok Ligating ClipTeleflex Medical · 2013 · 2 generations on3descendants
- K230480Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)Teleflex Medical · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021808 | Weck Hem-O-Lok Automatic Ligating Clip Applier | Weck | 2002 | — |
| +1 | 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 | K062914 | Hem-O-Lok Ligation Clip | Teleflex Medical | 2006 | — |
| +2 | K133202 | Hem-O-Lok Ligating Clip | Teleflex Medical | 2013 | — |
| +3 | K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) | Teleflex Medical | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | — | Weck Hem-o-lok clips Named without a submission number | |
| * | — | U.S.S.C. Autosuture Endoclip 5mm Disposable Clip Applier Named without a submission number | |
| * | — | Weck reusable ligating clip appliers Named without a submission number |
What descends from it? (11)
See all 112 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2019 | Class II | Z-0497-2020 | Under Investigation by firm | Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip… |
| Aug 22, 2008 | Not classified | Z-0158-2009 | Packaging process control | A hole in the sterile unit blister pack was detected that would compromise sterility. |
| Aug 22, 2008 | Not classified | Z-0160-2009 | Packaging process control | A hole in the sterile unit blister pack was detected that would compromise sterility. |
| Aug 22, 2008 | Not classified | Z-0157-2009 | Packaging process control | A hole in the sterile unit blister pack was detected that would compromise sterility. |
| Aug 22, 2008 | Not classified | Z-0156-2009 | Packaging process control | A hole in the sterile unit blister pack was detected that would compromise sterility. |
| Aug 22, 2008 | Not classified | Z-0159-2009 | Packaging process control | A hole in the sterile unit blister pack was detected that would compromise sterility. |
| Apr 12, 2006 | Not classified | Z-1099-06 | Other | The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K142777 (Teleflexmedical, Inc., 2014) has gone furthest, with 5 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?
Weck Hem-o-lok Automatic Ligating Clip Appliers are indicated for use as delivery devices for Hem-o-lok non-absorbable polymer ligating clips. Hem-o-lok ligating 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 structures 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/K021808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021808: Weck Hem-O-Lok Automatic Ligating Clip Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021808
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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