510(k) Report

510(k) · Cleared

Cleared

Horizon Surgical Ligating and Marking Clip

K901303510(k) TraditionalCleared Jun 5, 199077-day reviewClass II21 CFR 870.3250

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

Horizon Surgical, Inc. · DSS Clip, Vascular

Cleared on Jun 5, 1990 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Jun 5, 1990
Review
77 days
Class
Class II
Product code
DSS
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2023: 1 descendant cleared2009: 1 descendant cleared1990200020102020
  1. This deviceK901303 Horizon Surgical Ligating and Marking ClipHorizon Surgical, Inc. · 1990
  2. Descendant · cites it directly · 0 of its ownK230966 angiOCCLUDE Ligating ClipsA2 Medical Systems, LLC · 2023
  3. Descendant · cites it directly · 0 of its ownK091060 Vesocclude Ligating ClipVesocclude Medical, LLC · 2009

Most influential descendants

Showing 2 of 2 · See all
  • K230966angiOCCLUDE Ligating ClipsA2 Medical Systems, LLC · 2023 · cites it directly0descendants
  • K091060Vesocclude Ligating ClipVesocclude Medical, LLC · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K901303Horizon Surgical Ligating and Marking ClipHorizon Surgical, Inc.1990—
+1K230966angiOCCLUDE Ligating ClipsA2 Medical Systems, LLC2023—
+1K091060Vesocclude Ligating ClipVesocclude Medical, LLC2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
202310
FIG. 1 — Lineage of K901303, 1990–2023Source: 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 DSS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K230966angiOCCLUDE Ligating ClipsA2 Medical Systems, LLC20230
K091060Vesocclude Ligating ClipVesocclude Medical, LLC20090

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?

  • Of its descendants, K230966 (A2 Medical Systems, LLC, 2023) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DSS devices

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

FDA decisions per year · DSS

FDA has decided no DSS device since 2007.

Median 510(k) review, days · DSS

Too few DSS 510(k)s in any year since 2007 to give a median.

Recalls per year · DSS

No recall names DSS since 2007.

Adverse event reports per year · DSS

2in 2025

2007: 52008: 22009: 12012: 52014: 12016: 22017: 12019: 82020: 182022: 42023: 42025: 2
2007high 18 (2020) · low 0 (2010)2025

MAUDE reports naming product code DSS, 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
20070—05
20080—02
20090—01
20100—00
20110—00
20120—05
20130—00
20140—01
20150—00
20160—02
20170—01
20180—00
20190—08
20200—018
20210—00
20220—04
20230—04
20240—00
20250—02
20260—0—
Cite this page

510(k) Report. “K901303: Horizon Surgical Ligating and Marking Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K901303

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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