510(k) · Cleared
ClearedHem-O-Lok Ligation Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · FZP Clip, Implantable
Cleared on Nov 2, 2006 as substantially equivalent to K982941 (Weck Closure Systems, 1998) and 4 other predicates after a 36-day review. Its family tree reaches back 3 generations to 1992. 4 later devices descend from it.
- Decided
- Nov 2, 2006
- Review
- 36 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K922186 (1992). 6 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK922186 Hem-O-Lok -- ModificationLinvatec Corp. · 1992
- 2 generations backK982941 Hem-O-Lok Model Numbers 523900, 523970Weck Closure Systems · 1998 · Recalled
- 1 generation backK993157 Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer…Weck Closure Systems · 1999 · Recalled
- This deviceK062914 Hem-O-Lok Ligation ClipTeleflex Medical · 2006
- Descendant · cites it directly · 3 of its ownK133202 Hem-O-Lok Ligating ClipTeleflex Medical · 2013
- Descendant · 2 generations on · 1 of its ownK232970 Hem-o-lok® Ligating ClipsTeleflex Medical · 2024
- Descendant · 3 generations on · 0 of its ownK251054 Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical · 2025
- Descendant · 2 generations on · 0 of its ownK181852 Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K133202Hem-O-Lok Ligating ClipTeleflex Medical · 2013 · cites it directly3descendants
- K232970Hem-o-lok® Ligating ClipsTeleflex Medical · 2024 · 2 generations on1descendant
- K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical · 2025 · 3 generations on0descendants
- K181852Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922186 | Hem-O-Lok -- Modification | Linvatec Corp. | 1992 | — |
| −2 | K982941 | Hem-O-Lok Model Numbers 523900, 523970 | Weck Closure Systems | 1998 | 1 |
| −1 | K993157 | Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model… | Weck Closure Systems | 1999 | 1 |
| 0 (this device) | K062914 | Hem-O-Lok Ligation Clip | Teleflex Medical | 2006 | — |
| +1 | K133202 | Hem-O-Lok Ligating Clip | Teleflex Medical | 2013 | — |
| +2 | K232970 | Hem-o-lok® Ligating Clips | Teleflex Medical | 2024 | — |
| +3 | K251054 | Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips | Teleflex Medical | 2025 | — |
| +2 | K181852 | Percuvance Percutaneous Surgical System | Teleflexmedical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K982941 | Hem-O-Lok Model Numbers 523900, 523970Summary page 1…tantial Equivalence The Weck Hern-o-Lok® ligating clips are substantially equivalent to the The Weck Hem- o-Lokt clips previously cleared under 510(k)s: K982941, K993157, K003337, K030311. and the Hem-o-Lok® ML Automatic Endoscopic Applier cleared under 510(k) K021808.… | 1998 |
| * | K993157 | Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model 544240Summary page 1…quivalence The Weck Hern-o-Lok® ligating clips are substantially equivalent to the The Weck Hem- o-Lokt clips previously cleared under 510(k)s: K982941, K993157, K003337, K030311. and the Hem-o-Lok® ML Automatic Endoscopic Applier cleared under 510(k) K021808.… | 1999 |
| * | K003337 | Hem-O-Lok SMX, Model 544220; Hem-O-Lok ML, Model 544230; Hem-O-Lok MLX, Model 544240Summary page 1…e The Weck Hern-o-Lok® ligating clips are substantially equivalent to the The Weck Hem- o-Lokt clips previously cleared under 510(k)s: K982941, K993157, K003337, K030311. and the Hem-o-Lok® ML Automatic Endoscopic Applier cleared under 510(k) K021808.… | 2000 |
| * | K030311 | Hem-O-Lok XL ClipSummary page 1…The Weck Hern-o-Lok® ligating clips are substantially equivalent to the The Weck Hem- o-Lokt clips previously cleared under 510(k)s: K982941, K993157, K003337, K030311. and the Hem-o-Lok® ML Automatic Endoscopic Applier cleared under 510(k) K021808.… | 2003 |
| * | K021808 | Weck Hem-O-Lok Automatic Ligating Clip ApplierSummary page 1…o-Lokt clips previously cleared under 510(k)s: K982941, K993157, K003337, K030311. and the Hem-o-Lok® ML Automatic Endoscopic Applier cleared under 510(k) K021808. II DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2002 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133202 | Hem-O-Lok Ligating Clip | 2013 | 3 |
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 14 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 5 of the 6 ancestors have a recall of any class.
- Of its descendants, K133202 (Teleflex Medical, 2013) has gone furthest, with 3 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 as stated in the FDA summary.
https://510kreport.com/device/K062914 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062914: Hem-O-Lok Ligation Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062914
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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