510(k) · Cleared
ClearedLem Hemorrhoidal Ligator, Models a.5650, a.5660
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sapimed S.P.A. · FHN Ligator, Hemorrhoidal
Cleared on Sep 26, 2007 as substantially equivalent to K963166 (Patrick J. O'Regan, 1997) and 1 other predicate after a 180-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- Sep 26, 2007
- Review
- 180 days
- Class
- Class II
- Product code
- FHN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K963166 (1997). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK963166 O'regan LigatorPatrick J. O'Regan · 1997
- This deviceK070881 Lem Hemorrhoidal Ligator, Models a.5650, a.5660Sapimed S.P.A. · 2007
- Descendant · cites it directly · 3 of its ownK091519 Haemoband Multi-LigatorHaemoband Surgical, Ltd. · 2009
- Descendant · 2 generations on · 1 of its ownK131282 Nexus Hemorrhoid LigatorInx Medical · 2013
- Descendant · 3 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 4 of 4 · See all- K091519Haemoband Multi-LigatorHaemoband Surgical, Ltd. · 2009 · cites it directly3descendants
- K131282Nexus Hemorrhoid LigatorInx Medical · 2013 · 2 generations on1descendant
- K150718Wi-3 HAL-RAR SystemAgency For Medical Innovations GmbH · 2015 · 3 generations on0descendants
- K093497THD BandyThd Spa · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963166 | O'regan Ligator | Patrick J. O'Regan | 1997 | — |
| 0 (this device) | K070881 | Lem Hemorrhoidal Ligator, Models a.5650, a.5660 | Sapimed S.P.A. | 2007 | — |
| +1 | K091519 | Haemoband Multi-Ligator | Haemoband Surgical, Ltd. | 2009 | — |
| +2 | K131282 | Nexus Hemorrhoid Ligator | Inx Medical | 2013 | — |
| +3 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K963166 | O'regan LigatorSummary page 1…:II Legally Marketed Device: Company Product 510(k) Patrick J. O'Regan O'Regan Ligator K963166 Erchinger Medizintechnik Erchinger Hemrrohoidal ligator K000297 Description: The Sapimed LEM Disposable hemorrhoidal… | 1997 |
| * | K000297 | Erchinger Hemorrhoidal Ligators: Suction Ligators, Mod. Erchinger, Rudd, Mcgivney Mod.…Summary page 1…510(k) Patrick J. O'Regan O'Regan Ligator K963166 Erchinger Medizintechnik Erchinger Hemrrohoidal ligator K000297 Description: The Sapimed LEM Disposable hemorrhoidal ligators are used to apply a ligature or elastic ring around the base of t… | 2000 |
What descends from it? (4)
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?
How does its category compare?
All FHN devicesFHN Ligator, Hemorrhoidal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 LEM Hemorrhoidal ligators are used to cut off the blood flow to hemorrhoidal tissue
by means of a ligature or ring placed around the hemorrhoid base.
Hemorrhoidal ligators are intended for exclusive use by medical personnel trained in
proctology procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070881: Lem Hemorrhoidal Ligator, Models a.5650, a.5660.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070881
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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