510(k) · Cleared
ClearedTHD Disposable Anoscopes, Proctoscopes and Rectoscopes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thd Spa · FER Anoscope And Accessories
Cleared on Mar 1, 2011 as substantially equivalent to K091490 (Thd Spa, 2009) after a 78-day review. Its family tree reaches back 5 generations to 2000. 3 later devices descend from it.
- Decided
- Mar 1, 2011
- Review
- 78 days
- Class
- Class II
- Product code
- FER
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K993738 (2000). 9 ancestors in all, the oldest K770291 (1977). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK993738 Dispos-a-ScopeDispos-A-Scope · 2000
- 4 generations backK020702 O'regan Disposable AnoscopeCanadian Theatre Products, Ltd. · 2002
- 3 generations backK070913 Self-Light Disposable AnoscopeSapimed S.P.A. · 2007 · Recalled
- 2 generations backK080132 THD Disposable Anoscope/ProctoscopeThd Spa · 2008
- 1 generation backK091490 Family of THD Disposable Anoscopes/Proctoscopes/RectoscopesThd Spa · 2009
- This deviceK103647 THD Disposable Anoscopes, Proctoscopes and RectoscopesThd Spa · 2011
- Descendant · cites it directly · 1 of its ownK121135 THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-ScopeThd Spa · 2012
- Descendant · 2 generations on · 0 of its ownK230439 WellCare AnoscopeWell Care (Wuhan) Medical Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK133687 THD N-Ano AnoscopeThd Spa · 2013
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 |
|---|---|---|---|---|---|
| −5 | K993738 | Dispos-a-Scope | Dispos-A-Scope | 2000 | — |
| −4 | K020702 | O'regan Disposable Anoscope | Canadian Theatre Products, Ltd. | 2002 | — |
| −3 | K070913 | Self-Light Disposable Anoscope | Sapimed S.P.A. | 2007 | 1 |
| −2 | K080132 | THD Disposable Anoscope/Proctoscope | Thd Spa | 2008 | — |
| −1 | K091490 | Family of THD Disposable Anoscopes/Proctoscopes/Rectoscopes | Thd Spa | 2009 | — |
| 0 (this device) | K103647 | THD Disposable Anoscopes, Proctoscopes and Rectoscopes | Thd Spa | 2011 | — |
| +1 | K121135 | THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-Scope | Thd Spa | 2012 | — |
| +2 | K230439 | WellCare Anoscope | Well Care (Wuhan) Medical Technology Co., Ltd. | 2023 | — |
| +1 | K133687 | THD N-Ano Anoscope | Thd Spa | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1981 | 1 | 0 |
| 1996 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2023 | 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 10.7 · 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? (1)
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 |
|---|---|---|---|
| * | K091490 | Family of THD Disposable Anoscopes/Proctoscopes/RectoscopesSummary page 2…the previous cleared device, but they are ready to use for the physician. The THD Light-scope models are designed with the white tip as the previous cleared rectoscope (K091490). This characteristic improves the light focus to the end of the device with a better visibility of the treated area. The THD Lig… | 2009 |
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 11 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K121135 (Thd Spa, 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FER devicesFER Anoscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103647: THD Disposable Anoscopes, Proctoscopes and Rectoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103647
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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