510(k) Report

510(k) · Cleared

Recalled · 2004

Hem-O-Lok Model Numbers 523900, 523970

K982941510(k) TraditionalCleared Nov 19, 199890-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 Closure Systems · FZP Clip, Implantable

Cleared on Nov 19, 1998 as substantially equivalent to K922186 (Linvatec Corp., 1992) after a 90-day review. Its family tree reaches back 1 generation to 1992. 9 later devices descend from it. It has been recalled once.

Decided
Nov 19, 1998
Review
90 days
Class
Class II
Product code
FZP
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K922186 (1992). 9 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2006: 1 descendant cleared2013: 1 descendant cleared2016: 2 descendants cleared2025: 2 descendants cleared2018: 1 descendant cleared2024: 1 descendant clearedK922186 · Hem-O-Lok -- Modification · Linvatec Corp. · 19921990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K922186 · Hem-O-Lok -- Modification · Linvatec Corp. · 19920
  1. Root · 1 generation backK922186 Hem-O-Lok -- ModificationLinvatec Corp. · 1992
  2. This deviceK982941 Hem-O-Lok Model Numbers 523900, 523970Weck Closure Systems · 1998
  3. Descendant · cites it directly · 8 of its ownK993157 Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer…Weck Closure Systems · 1999 · Recalled
  4. Descendant · cites it directly · 4 of its ownK062914 Hem-O-Lok Ligation ClipTeleflex Medical · 2006
  5. Descendant · 2 generations on · 3 of its ownK133202 Hem-O-Lok Ligating ClipTeleflex Medical · 2013
  6. Descendant · 3 generations on · 1 of its ownK232970 Hem-o-lok® Ligating ClipsTeleflex Medical · 2024
  7. Descendant · 2 generations on · 0 of its ownK250643 Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd. · 2025

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

1999: 12006: 12013: 12016: 22018: 12024: 12025: 2
1999high 2 (2016) · low 0 (2000)2026

Most influential descendants

Showing 5 of 9 · See all
  • K993157Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model 544240Weck Closure Systems · 1999 · cites it directly8descendants
  • 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 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K922186Hem-O-Lok -- ModificationLinvatec Corp.1992—
0 (this device)K982941Hem-O-Lok Model Numbers 523900, 523970Weck Closure Systems1998—
+1K993157Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model…Weck Closure Systems19991
+1K062914Hem-O-Lok Ligation ClipTeleflex Medical2006—
+2K133202Hem-O-Lok Ligating ClipTeleflex Medical2013—
+3K232970Hem-o-lok® Ligating ClipsTeleflex Medical2024—
+2K250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200610
201310
201620
201810
202410
202520
FIG. 1 — Lineage of K982941, 1992–2025Source: 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), 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
*K922186Hem-O-Lok -- Modification
Summary page 1
…ich the submitter claims equivalence The Weck Closure Systems Hem-0-Lok® clip is substantially equivalent to Hem-O-Lok® clips cleared under Bristol Myers’ 510(k) number K922186. 4. Description of the Device Weck Closure System’s Hem-O-Lok® ligation clip is a manually applied hemostatic clip intended to…
Linvatec Corp.1992—

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K993157Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model 544240Weck Closure Systems19998
K062914Hem-O-Lok Ligation ClipTeleflex Medical20064

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 23, 2004Not classifiedZ-0547-04OtherMalformation of the Hem-o-lok SMX clip.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K993157 (Weck Closure Systems, 1999) has gone furthest, with 8 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-0-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should match clip size to the size of the vessel or tissue structure to be ligated.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Weck Closure Systems

6 FDA decisions under this applicant name. See the company

  • K011660Weck Cardiac Pacing WiresWeck Closure Systems · 2001
  • K003337Hem-O-Lok SMX, Model 544220; Hem-O-Lok ML, Model 544230; Hem-O-Lok MLX, Model 544240Weck Closure Systems · 20002 recalls
  • K993157Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model 544240Weck Closure Systems · 19991 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/K982941 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982941: Hem-O-Lok Model Numbers 523900, 523970.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982941

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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