510(k) Report

510(k) · Cleared

Recalled · 2006

Hem-O-Lok XL Clip

K030311510(k) SpecialCleared Feb 26, 200327-day reviewClass II21 CFR 878.4300Recalls 1

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

Weck · FZP Clip, Implantable

Cleared on Feb 26, 2003 after a 27-day review. The FDA summary names its predicate without a number. 26 later devices descend from it. It has been recalled once.

Decided
Feb 26, 2003
Review
27 days
Class
Class II
Product code
FZP
Recalls
1
Predicates
0

26 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2016: 3 descendants cleared2022: 2 descendants cleared2013: 2 descendants cleared2010: 1 descendant cleared2006: 1 descendant cleared2015: 1 descendant cleared2017: 3 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared2018: 3 descendants cleared2024: 1 descendant cleared2025: 1 descendant cleared2019: 1 descendant cleared2021: 1 descendant cleared2023: 2 descendants cleared2026: 2 descendants cleared200020052010201520202025
  1. This deviceK030311 Hem-O-Lok XL ClipWeck · 2003
  2. Descendant · cites it directly · 18 of its ownK093679 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2010
  3. Descendant · 2 generations on · 15 of its ownK122276 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012
  4. Descendant · 3 generations on · 10 of its ownK153500 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V…AtriCure, Inc. · 2016
  5. Descendant · 4 generations on · 9 of its ownK173031 AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc. · 2017
  6. Descendant · 5 generations on · 8 of its ownK180010 AtriClip FLEX-VAtriCure, Inc. · 2018

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2006: 12010: 12012: 12013: 22014: 12015: 12016: 32017: 32018: 32019: 12021: 12022: 22023: 22024: 12025: 12026: 2
2006high 3 (2016) · low 0 (2007)2026

Most influential descendants

Showing 5 of 26 · See all
  • K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc. · 2010 · cites it directly18descendants
  • K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012 · 2 generations on15descendants
  • K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc. · 2016 · 3 generations on10descendants
  • K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc. · 2017 · 4 generations on9descendants
  • K180010AtriClip FLEX-VAtriCure, Inc. · 2018 · 5 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030311Hem-O-Lok XL ClipWeck2003—
+1K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc.2010—
+2K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.2012—
+3K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc.2016—
+4K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.2017—
+5K180010AtriClip FLEX-VAtriCure, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201010
201210
201320
201410
201510
201630
201730
201830
201910
202110
202220
202320
202410
202510
202620
FIG. 1 — Lineage of K030311, 2003–2026Source: 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), 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. #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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—previously cleared Weck Hem-o-lok clip sizes
Named without a submission number
—

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc.201018
K062914Hem-O-Lok Ligation ClipTeleflex Medical20064
K133202Hem-O-Lok Ligating ClipTeleflex Medical20133
K220006angioLOCK Polymer Ligating ClipA2 Medical Systems, LLC20220
K152082Vesocclude Polymer Ligating ClipVesocclude Medical, LLC20160

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 12, 2006Not classifiedZ-1098-06OtherThe 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, K093679 (AtriCure, Inc., 2010) has gone furthest, with 18 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—

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.

More from Weck

2 FDA decisions under this applicant name. See the company

  • K021808Weck Hem-O-Lok Automatic Ligating Clip ApplierWeck · 20027 recalls

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/K030311 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030311: Hem-O-Lok XL Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030311

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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