510(k) · Cleared
ClearedHX-20/21-1 Endoscopic Ligator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · MND Ligator, Esophageal
Cleared on Oct 30, 1997 after a 344-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Oct 30, 1997
- Review
- 344 days
- Class
- Class II
- Product code
- MND
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964661 | HX-20/21-1 Endoscopic Ligator | Olympus America, Inc. | 1997 | — |
| +1 | K172985 | Ligation Device | Leo Medical Co., Ltd. | 2018 | — |
| +1 | K984255 | Olympus HX-20 Series Ligating Device | Olympus Corp of America | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2018 | 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 MND? 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
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | Endoscopic Ligators by C.R. Bard Named without a submission number | |
| * | — | Endoscopic Ligators by Wilson-Cook Named without a submission number | |
| * | — | Endoscopic Ligators by Microvasive Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K172985 (Leo Medical Co., Ltd., 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MND devicesMND Ligator, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MND
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · MND
Too few MND 510(k)s in any year since 2007 to give a median.
Recalls per year · MND
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MND
1,083in 2025
MAUDE reports naming product code MND, 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 | 0 | — | 0 | 84 |
| 2008 | 1 | — | 0 | 451 |
| 2009 | 1 | — | 0 | 1,161 |
| 2010 | 0 | — | 1 | 600 |
| 2011 | 0 | — | 1 | 672 |
| 2012 | 0 | — | 0 | 719 |
| 2013 | 1 | — | 0 | 750 |
| 2014 | 0 | — | 0 | 117 |
| 2015 | 0 | — | 0 | 76 |
| 2016 | 0 | — | 0 | 94 |
| 2017 | 0 | — | 0 | 88 |
| 2018 | 0 | — | 0 | 124 |
| 2019 | 0 | — | 0 | 294 |
| 2020 | 0 | — | 1 | 345 |
| 2021 | 0 | — | 0 | 674 |
| 2022 | 0 | — | 0 | 808 |
| 2023 | 0 | — | 0 | 689 |
| 2024 | 0 | — | 0 | 921 |
| 2025 | 0 | — | 1 (1) | 1,083 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Olympus HX -20-1 Endoscopic Ligator has been designed to be used with Olympus endoscopes in delivering a MAJ-254 Standard Ligation Loop or MAJ-340 Small Ligation Loop, designed to prevent or control bleeding following polypectomy of pedunculated polvps.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964661: HX-20/21-1 Endoscopic Ligator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964661
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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