510(k) · Cleared
ClearedWi-3 HAL-RAR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agency For Medical Innovations GmbH · FHN Ligator, Hemorrhoidal
Cleared on Jun 12, 2015 as substantially equivalent to K061831 (Medchannel, LLC, 2006) and 2 other predicates after an 85-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Jun 12, 2015
- Review
- 85 days
- Class
- Class II
- Product code
- FHN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K930458 (1995). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK930458 Multi-Dop LDantec Medical, Inc. · 1995
- 4 generations backK041915 Hemo-DopDwl Elektronische Systeme GmbH · 2004
- 3 generations backK052067 Doppler Guided Proctoscope, Model 500HMultigon Industries, Inc. · 2005
- 2 generations backK070815 THDG.F. S.R.L. · 2007
- 1 generation backK081429 THD SlideThd Spa · 2008
- This deviceK150718 Wi-3 HAL-RAR SystemAgency For Medical Innovations GmbH · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930458 | Multi-Dop L | Dantec Medical, Inc. | 1995 | — |
| −4 | K041915 | Hemo-Dop | Dwl Elektronische Systeme GmbH | 2004 | — |
| −3 | K052067 | Doppler Guided Proctoscope, Model 500H | Multigon Industries, Inc. | 2005 | — |
| −2 | K070815 | THD | G.F. S.R.L. | 2007 | — |
| −1 | K081429 | THD Slide | Thd Spa | 2008 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K061831 | Medchannel HTS SystemSummary page 5…‐3 HAL‐RAR System is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K061831 MedChannel HTS System* / MedChannel, LLC K081429 THD Slide / THD S.p.A K131282… | 2006 |
| * | K081429 | THD SlideSummary page 5…r Predicate Device Name / Manufacturer Primary Predicate K061831 MedChannel HTS System* / MedChannel, LLC K081429 THD Slide / THD S.p.A K131282 Nexus™ Hemorrhoid Ligator / inx Medical * The MedChannel HTS System was purchas… | 2008 |
| * | K131282 | Nexus Hemorrhoid LigatorSummary page 5…er Primary Predicate K061831 MedChannel HTS System* / MedChannel, LLC K081429 THD Slide / THD S.p.A K131282 Nexus™ Hemorrhoid Ligator / inx Medical * The MedChannel HTS System was purchased by A.M.I and rebranded as the HAL‐RAR… | 2013 |
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?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- None of the 12 ancestors has a recall.
How does its category compare?
All FHN devicesFHN Ligator, Hemorrhoidal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150718: Wi-3 HAL-RAR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150718
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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