510(k) · Cleared
Recalled · Class II · 2012Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model 544240
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Weck Closure Systems · FZP Clip, Implantable
Cleared on Dec 17, 1999 as substantially equivalent to K982941 (Weck Closure Systems, 1998) after an 87-day review. Its family tree reaches back 2 generations to 1992. 8 later devices descend from it. It has been recalled once.
- Decided
- Dec 17, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- FZP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922186 (1992). 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK922186 Hem-O-Lok -- ModificationLinvatec Corp. · 1992
- 1 generation backK982941 Hem-O-Lok Model Numbers 523900, 523970Weck Closure Systems · 1998 · Recalled
- This deviceK993157 Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer…Weck Closure Systems · 1999
- 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 · 1 of its ownK232970 Hem-o-lok® Ligating ClipsTeleflex Medical · 2024
- Descendant · cites it directly · 0 of its ownK250643 Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd. · 2025
- Descendant · 4 generations on · 0 of its ownK251054 Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K062914Hem-O-Lok Ligation ClipTeleflex Medical · 2006 · cites it directly4descendants
- K133202Hem-O-Lok Ligating ClipTeleflex Medical · 2013 · 2 generations on3descendants
- K232970Hem-o-lok® Ligating ClipsTeleflex Medical · 2024 · 3 generations on1descendant
- K250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd. · 2025 · cites it directly0descendants
- K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922186 | Hem-O-Lok -- Modification | Linvatec Corp. | 1992 | — |
| −1 | K982941 | Hem-O-Lok Model Numbers 523900, 523970 | Weck Closure Systems | 1998 | 1 |
| 0 (this device) | K993157 | Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model… | Weck Closure Systems | 1999 | — |
| +1 | K062914 | Hem-O-Lok Ligation Clip | Teleflex Medical | 2006 | — |
| +2 | K133202 | Hem-O-Lok Ligating Clip | Teleflex Medical | 2013 | — |
| +3 | K232970 | Hem-o-lok® Ligating Clips | Teleflex Medical | 2024 | — |
| +1 | K250643 | Disposable Polymer Ligation Clips | Hangzhou Kangji Medical Instrument Co., Ltd. | 2025 | — |
| +4 | K251054 | Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips | Teleflex Medical | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K982941 | Hem-O-Lok Model Numbers 523900, 523970Summary page 1…submitter claims equivalence The Weck Closure Systems Hem-O-Lok® clip is substantially equivalent to Hem-O-Lok® clips cleared under Weck’s previous 510(k) filing number 982941. Description of the Device Weck Closure System’s Hem-O-Lok® ligation clip is a manually applied hemostatic clip intended to con… | 1998 |
What descends from it? (8)
4 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 |
|---|---|---|---|---|
| Sep 25, 2012 | Class II | Z-0078-2013 | Packaging process control | Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K062914 (Teleflex Medical, 2006) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K982941.
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?
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 structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
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/K993157 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993157: Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model 544240.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993157
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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