510(k) Report

510(k) · Cleared

Recalled · 2006

Hem-O-Lok SMX, Model 544220; Hem-O-Lok ML, Model 544230; Hem-O-Lok MLX, Model 544240

K003337510(k) TraditionalCleared Dec 21, 200057-day reviewClass II21 CFR 878.4300Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Weck Closure Systems · FZP Clip, Implantable

Cleared on Dec 21, 2000 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled 2 times.

Decided
Dec 21, 2000
Review
57 days
Class
Class II
Product code
FZP
Recalls
2
Predicates
0

7 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2002: 1 descendant cleared2006: 1 descendant cleared2013: 1 descendant cleared2018: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK003337 Hem-O-Lok SMX, Model 544220; Hem-O-Lok ML, Model 544230; Hem-O-Lok…Weck Closure Systems · 2000
  2. Descendant · cites it directly · 4 of its ownK062914 Hem-O-Lok Ligation ClipTeleflex Medical · 2006
  3. Descendant · 2 generations on · 3 of its ownK133202 Hem-O-Lok Ligating ClipTeleflex Medical · 2013
  4. Descendant · 3 generations on · 1 of its ownK232970 Hem-o-lok® Ligating ClipsTeleflex Medical · 2024
  5. Descendant · 4 generations on · 0 of its ownK251054 Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical · 2025
  6. Descendant · 3 generations on · 0 of its ownK181852 Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2018

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2002: 12006: 12013: 12016: 12018: 12024: 12025: 1
2002high 1 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 7 · 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
  • K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical · 2025 · 4 generations on0descendants
  • K181852Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003337Hem-O-Lok SMX, Model 544220; Hem-O-Lok ML, Model 544230; Hem-O-Lok MLX, Model…Weck Closure Systems2000—
+1K062914Hem-O-Lok Ligation ClipTeleflex Medical2006—
+2K133202Hem-O-Lok Ligating ClipTeleflex Medical2013—
+3K232970Hem-o-lok® Ligating ClipsTeleflex Medical2024—
+4K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical2025—
+3K181852Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200610
201310
201610
201810
202410
202510
FIG. 1 — Lineage of K003337, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (7)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062914Hem-O-Lok Ligation ClipTeleflex Medical20064
K152082Vesocclude Polymer Ligating ClipVesocclude Medical, LLC20160
K021745VasclipVmbc, LLC20020

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 12, 2006Not classifiedZ-1096-06OtherThe 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…
Apr 12, 2006Not classifiedZ-1097-06OtherThe 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…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K062914 (Teleflex Medical, 2006) has gone furthest, with 4 descendants of its own.

How does its category compare?

All FZP devices

FZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FZP

5in 2025

2007: 62008: 42009: 32010: 62011: 32012: 22013: 32014: 32015: 82016: 52017: 42018: 42019: 12020: 22022: 32023: 32024: 22025: 52026 (partial year): 2
2007high 8 (2015) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FZP

90in 2025

2007: 31 days median2008: 23 days median2009: 22 days median2010: 47 days median2011: 124 days median2013: 47 days median2014: 29 days median2015: 182 days median2016: 72 days median2017: 29 days median2018: 143 days median2022: 227 days median2023: 65 days median2025: 90 days median
2007high 227 (2022) · low 22 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FZP

1in 2020

2007: 12008: 62010: 12012: 12014: 12016: 22017: 12019: 32020: 1
2007high 6 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FZP

1,902in 2025

2007: 1,8772008: 9812009: 2,1602010: 2,3672011: 1,6782012: 1,6772013: 2,3812014: 2,3202015: 2,8712016: 1,8402017: 2,5942018: 2,7182019: 2,9032020: 1,7602021: 1,7592022: 1,5752023: 1,9182024: 2,0672025: 1,902
2007high 2,903 (2019) · low 981 (2008)2025

MAUDE reports naming product code FZP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200763111,877
20084236981
200932202,160
201064712,367
2011312401,678
20122—11,677
201334702,381
201432912,320
2015818202,871
201657221,840
201742912,594
2018414302,718
20191—32,903
20202—11,760
20210—01,759
2022322701,575
202336501,918
20242—02,067
202559001,902
20262—0—

More from Weck Closure Systems

6 FDA decisions under this applicant name. See the company

  • K011660Weck Cardiac Pacing WiresWeck Closure Systems · 2001
  • K993157Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model 544240Weck Closure Systems · 19991 recall
  • K982941Hem-O-Lok Model Numbers 523900, 523970Weck Closure Systems · 19981 recall
  • K982944Hem-O-Lock, Model 523935Weck Closure Systems · 1998
  • K982313Horizon Titanium Clips, Horizon Tantalum ClipsWeck Closure Systems · 19981 recall

Recent decisions in FZP

The FZP category page

  • K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L. · 2026
  • K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical Corporation · 2026
  • K253903InnoClip Disposable Clip ApplierTaiwan Surgical Corporation · 2025
  • K253781InnoClip Clip ApplierTaiwan Surgical Corporation · 2025
  • K250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd. · 2025

https://510kreport.com/device/K003337 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003337: Hem-O-Lok SMX, Model 544220; Hem-O-Lok ML, Model 544230; Hem-O-Lok MLX, 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/K003337

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026