510(k) · Cleared
ClearedHaemoband Multi-Ligator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemoband Surgical, Ltd. · FHN Ligator, Hemorrhoidal
Cleared on Jul 28, 2009 as substantially equivalent to K070881 (Sapimed S.P.A., 2007) and 1 other predicate after a 67-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it.
- Decided
- Jul 28, 2009
- Review
- 67 days
- Class
- Class II
- Product code
- FHN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K963166 (1997). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK963166 O'regan LigatorPatrick J. O'Regan · 1997
- 1 generation backK070881 Lem Hemorrhoidal Ligator, Models a.5650, a.5660Sapimed S.P.A. · 2007
- This deviceK091519 Haemoband Multi-LigatorHaemoband Surgical, Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK131282 Nexus Hemorrhoid LigatorInx Medical · 2013
- Descendant · 2 generations on · 0 of its ownK150718 Wi-3 HAL-RAR SystemAgency For Medical Innovations GmbH · 2015
- Descendant · cites it directly · 0 of its ownK093497 THD BandyThd Spa · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963166 | O'regan Ligator | Patrick J. O'Regan | 1997 | — |
| −1 | K070881 | Lem Hemorrhoidal Ligator, Models a.5650, a.5660 | Sapimed S.P.A. | 2007 | — |
| 0 (this device) | K091519 | Haemoband Multi-Ligator | Haemoband Surgical, Ltd. | 2009 | — |
| +1 | K131282 | Nexus Hemorrhoid Ligator | Inx Medical | 2013 | — |
| +2 | K150718 | Wi-3 HAL-RAR System | Agency For Medical Innovations GmbH | 2015 | — |
| +1 | K093497 | THD Bandy | Thd Spa | 2010 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K070881 | Lem Hemorrhoidal Ligator, Models a.5650, a.5660Summary page 2…Proposed Device Predicate Device 510(k) Numbers & K070881 K000297 Manufacturers SAPI MED S.p.a. Erch… | 2007 |
| * | K000297 | Erchinger Hemorrhoidal Ligators: Suction Ligators, Mod. Erchinger, Rudd, Mcgivney Mod.…Summary page 2…Proposed Device Predicate Device 510(k) Numbers & K070881 K000297 Manufacturers SAPI MED S.p.a. Erchinger Medizintechnik Device… | 2000 |
What descends from it? (3)
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K131282 (Inx Medical, 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K070881.
How does its category compare?
All FHN devicesFHN Ligator, Hemorrhoidal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Haemoband Multi-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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091519: Haemoband Multi-Ligator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091519
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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