510(k) · Cleared
Recalled · Class II · 2021Self-Light Disposable Anoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sapimed S.P.A. · FER Anoscope And Accessories
Cleared on Aug 10, 2007 as substantially equivalent to K020702 (Canadian Theatre Products, Ltd., 2002) and 2 other predicates after a 130-day review. Its family tree reaches back 2 generations to 2000. 11 later devices descend from it. It has been recalled once.
- Decided
- Aug 10, 2007
- Review
- 130 days
- Class
- Class II
- Product code
- FER
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K993738 (2000). 4 ancestors in all, the oldest K810227 (1981). 11 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK993738 Dispos-a-ScopeDispos-A-Scope · 2000
- 1 generation backK020702 O'regan Disposable AnoscopeCanadian Theatre Products, Ltd. · 2002
- This deviceK070913 Self-Light Disposable AnoscopeSapimed S.P.A. · 2007
- Descendant · cites it directly · 6 of its ownK080132 THD Disposable Anoscope/ProctoscopeThd Spa · 2008
- Descendant · 2 generations on · 4 of its ownK091490 Family of THD Disposable Anoscopes/Proctoscopes/RectoscopesThd Spa · 2009
- Descendant · 3 generations on · 3 of its ownK103647 THD Disposable Anoscopes, Proctoscopes and RectoscopesThd Spa · 2011
- Descendant · 4 generations on · 1 of its ownK121135 THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-ScopeThd Spa · 2012
- Descendant · cites it directly · 0 of its ownK250645 SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16…Haemoband Surgical, Ltd. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K080132THD Disposable Anoscope/ProctoscopeThd Spa · 2008 · cites it directly6descendants
- K091490Family of THD Disposable Anoscopes/Proctoscopes/RectoscopesThd Spa · 2009 · 2 generations on4descendants
- K103647THD Disposable Anoscopes, Proctoscopes and RectoscopesThd Spa · 2011 · 3 generations on3descendants
- K121135THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-ScopeThd Spa · 2012 · 4 generations on1descendant
- K250645SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)Haemoband Surgical, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993738 | Dispos-a-Scope | Dispos-A-Scope | 2000 | — |
| −1 | K020702 | O'regan Disposable Anoscope | Canadian Theatre Products, Ltd. | 2002 | — |
| 0 (this device) | K070913 | Self-Light Disposable Anoscope | Sapimed S.P.A. | 2007 | — |
| +1 | K080132 | THD Disposable Anoscope/Proctoscope | Thd Spa | 2008 | — |
| +2 | K091490 | Family of THD Disposable Anoscopes/Proctoscopes/Rectoscopes | Thd Spa | 2009 | — |
| +3 | K103647 | THD Disposable Anoscopes, Proctoscopes and Rectoscopes | Thd Spa | 2011 | — |
| +4 | K121135 | THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-Scope | Thd Spa | 2012 | — |
| +1 | K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope… | Haemoband Surgical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 FER? 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 FER device
- #1 K250645 SleeveLUX 24 Anoscope/Proctoscope (P2001)…score 10.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K020702 | O'regan Disposable AnoscopeSummary page 1…Device: Company Product 510(k) Patrick J. O'Regan O'Regan Disposable Anoscope K020702 Welch Allyn, Inc Model #53110 Disposable Anoscope K810227 North EOS Industries EOS Brand Disp… | 2002 |
| * | K810227 | Model #53110 Disposable AnoscopeSummary page 1…510(k) Patrick J. O'Regan O'Regan Disposable Anoscope K020702 Welch Allyn, Inc Model #53110 Disposable Anoscope K810227 North EOS Industries EOS Brand Disposable Proctoscope K954614 Description: The Sapimed Self Light ® Dispo… | 1981 |
| * | K954614 | Eos Brand Disposable ProctoscopeSummary page 1…K020702 Welch Allyn, Inc Model #53110 Disposable Anoscope K810227 North EOS Industries EOS Brand Disposable Proctoscope K954614 Description: The Sapimed Self Light ® Disposable Anoscopes are clear, transparent plastic anoscopes in a range of sizes to suit… | 1996 |
What descends from it? (11)
See all 115 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2021 | Class II | Z-1901-2021 | Process control | Due to issue with product sterility. Sterilization service provider had falsified records. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FER devicesFER Anoscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FER
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FER
Too few FER 510(k)s in any year since 2007 to give a median.
Recalls per year · FER
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FER
3in 2025
MAUDE reports naming product code FER, 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 | 0 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 1 | 4 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sapimed Self Light® Disposable Anoscopes are intended for physician use to examine the anal sphincter and anus, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070913 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070913: Self-Light Disposable Anoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070913
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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