510(k) · Cleared
ClearedNexus Hemorrhoid Ligator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inx Medical · FHN Ligator, Hemorrhoidal
Cleared on Jul 11, 2013 as substantially equivalent to K091519 (Haemoband Surgical, Ltd., 2009) and 1 other predicate after a 66-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Jul 11, 2013
- Review
- 66 days
- Class
- Class II
- Product code
- FHN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K963166 (1997). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK963166 O'regan LigatorPatrick J. O'Regan · 1997
- 2 generations backK070881 Lem Hemorrhoidal Ligator, Models a.5650, a.5660Sapimed S.P.A. · 2007
- 1 generation backK091519 Haemoband Multi-LigatorHaemoband Surgical, Ltd. · 2009
- This deviceK131282 Nexus Hemorrhoid LigatorInx Medical · 2013
- Descendant · cites it directly · 0 of its ownK150718 Wi-3 HAL-RAR SystemAgency For Medical Innovations GmbH · 2015
Most influential descendants
Showing 1 of 1 · See all- K150718Wi-3 HAL-RAR SystemAgency For Medical Innovations GmbH · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963166 | O'regan Ligator | Patrick J. O'Regan | 1997 | — |
| −2 | K070881 | Lem Hemorrhoidal Ligator, Models a.5650, a.5660 | Sapimed S.P.A. | 2007 | — |
| −1 | K091519 | Haemoband Multi-Ligator | Haemoband Surgical, Ltd. | 2009 | — |
| 0 (this device) | K131282 | Nexus Hemorrhoid Ligator | Inx Medical | 2013 | — |
| +1 | K150718 | Wi-3 HAL-RAR System | Agency For Medical Innovations GmbH | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 FHN? 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 FHN device
- #1 K213223 Multi-Band Ligatorscore 3.5 · 1 generation · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K091519 | Haemoband Multi-LigatorSummary page 2…Technology and Mode of Operation - * The internal mechanism for holding and banding the ligator bands is identical to the predicate Haemnoband MUlti-Ligator (K091 519) * l'he incorporation of an internal suction / vacuum source is equivalent to the predicate O'Regan - O'Regan Ligator (… | 2009 |
| * | K963166 | O'regan LigatorSummary page 1…00, Class 11 Device: Multi-Ligator Predicate Devices: K(091519 - Haemoband - Multi-Ligator K963 166 - O'Regan - O'Regan Ligator Device Description: The mnx Medical NCXUSTM Hemorrhoid Ligator is a simple handheld device which all… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150718 | Wi-3 HAL-RAR System | 2015 | 0 |
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?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K150718 (Agency For Medical Innovations GmbH, 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K091519.
How does its category compare?
All FHN devicesFHN Ligator, Hemorrhoidal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FHN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · FHN
Too few FHN 510(k)s in any year since 2007 to give a median.
Recalls per year · FHN
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FHN
7in 2025
MAUDE reports naming product code FHN, 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 | 1 | — | 0 | 11 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 1 | — | 2 | 3 |
| 2010 | 1 | — | 1 | 17 |
| 2011 | 0 | — | 1 | 9 |
| 2012 | 0 | — | 0 | 11 |
| 2013 | 1 | — | 0 | 102 |
| 2014 | 0 | — | 0 | 208 |
| 2015 | 1 | — | 0 | 228 |
| 2016 | 0 | — | 0 | 202 |
| 2017 | 0 | — | 0 | 303 |
| 2018 | 1 | — | 0 | 318 |
| 2019 | 0 | — | 0 | 372 |
| 2020 | 0 | — | 0 | 70 |
| 2021 | 0 | — | 0 | 16 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 0 | — | 0 | 47 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The inx Medical NexusTh Hemorrhoid Ligator includes suction and ligation capabilities. The ligator is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base.
It is for use only by trained medical personnel in hospitals, clinics, and doctors' offices.
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/K131282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131282: Nexus Hemorrhoid Ligator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131282
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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