510(k) · Cleared
ClearedTHD Bandy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thd Spa · FHN Ligator, Hemorrhoidal
Cleared on Jul 15, 2010 as substantially equivalent to K070881 (Sapimed S.P.A., 2007) and 2 other predicates after a 245-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Jul 15, 2010
- Review
- 245 days
- Class
- Class II
- Product code
- FHN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K993738 (2000). 12 ancestors in all, the oldest K770291 (1977). No later device cites it as a predicate yet.
- Root · 4 generations backK993738 Dispos-a-ScopeDispos-A-Scope · 2000
- 3 generations backK020702 O'regan Disposable AnoscopeCanadian Theatre Products, Ltd. · 2002
- 2 generations backK070913 Self-Light Disposable AnoscopeSapimed S.P.A. · 2007 · Recalled
- 1 generation backK080132 THD Disposable Anoscope/ProctoscopeThd Spa · 2008
- This deviceK093497 THD BandyThd Spa · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K993738 | Dispos-a-Scope | Dispos-A-Scope | 2000 | — |
| −3 | K020702 | O'regan Disposable Anoscope | Canadian Theatre Products, Ltd. | 2002 | — |
| −2 | K070913 | Self-Light Disposable Anoscope | Sapimed S.P.A. | 2007 | 1 |
| −1 | K080132 | THD Disposable Anoscope/Proctoscope | Thd Spa | 2008 | — |
| 0 (this device) | K093497 | THD Bandy | Thd Spa | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1981 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 |
|---|---|---|---|
| * | K070881 | Lem Hemorrhoidal Ligator, Models a.5650, a.5660Summary page 1…Device name S510(k) Number Sapimed S.p.A. LEM K070881 Haemoband Surgical Haemoband Multi Ligator K091519… | 2007 |
| * | K091519 | Haemoband Multi-LigatorSummary page 1…LEM K070881 Haemoband Surgical Haemoband Multi Ligator K091519 LTD _ _ _ _ _ _ _ _ _ THD S.p.A.… | 2009 |
| * | K080132 | THD Disposable Anoscope/ProctoscopeSummary page 1…D _ _ _ _ _ _ _ _ _ THD S.p.A. THD Disposable K080132 Anoscope/Proctoscope _________ THD S.p.A.… | 2008 |
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 10 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 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. 2010, 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 THD Bandy is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base.
The THD Bandy is to be used for exclusive use by medical personnel trained in proctology procedures.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K093497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093497: THD Bandy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093497
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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