510(k) · Cleared
ClearedOlympus HX-20 Series Ligating Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp of America · MND Ligator, Esophageal
Cleared on Jan 12, 1999 as substantially equivalent to K964661 (Olympus America, Inc., 1997) after a 43-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jan 12, 1999
- Review
- 43 days
- Class
- Class II
- Product code
- MND
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964661 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964661 HX-20/21-1 Endoscopic LigatorOlympus America, Inc. · 1997
- This deviceK984255 Olympus HX-20 Series Ligating DeviceOlympus Corp of America · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964661 | HX-20/21-1 Endoscopic Ligator | Olympus America, Inc. | 1997 | — |
| 0 (this device) | K984255 | Olympus HX-20 Series Ligating Device | Olympus Corp of America | 1999 | — |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964661 | HX-20/21-1 Endoscopic LigatorSummary page 1…or Common/Usual Name: HX-20-1 Endoscopic Ligator Classification Name: Endoscope and Accessories 21 CFR 876.1500 Predicate Device: Olympus HX-20-1 Endoscopic Ligator, #K964661 Contact Person: Laura Storms-Tyler Olympus America, Inc. Regulatory Affairs 2 Corporate Center Drive Melville, NY 11747-3157 (… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K964661.
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?
Olympus HX-20-1 Ligating device 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 polyps.
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/K984255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984255: Olympus HX-20 Series Ligating Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984255
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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