510(k) · Cleared
ClearedO'regan Disposable Anoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canadian Theatre Products, Ltd. · FER Anoscope And Accessories
Cleared on Mar 29, 2002 as substantially equivalent to K993738 (Dispos-A-Scope, 2000) after a 25-day review. Its family tree reaches back 1 generation to 2000. 13 later devices descend from it.
- Decided
- Mar 29, 2002
- Review
- 25 days
- Class
- Class II
- Product code
- FER
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993738 (2000). 13 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK993738 Dispos-a-ScopeDispos-A-Scope · 2000
- This deviceK020702 O'regan Disposable AnoscopeCanadian Theatre Products, Ltd. · 2002
- Descendant · cites it directly · 11 of its ownK070913 Self-Light Disposable AnoscopeSapimed S.P.A. · 2007 · Recalled
- Descendant · 2 generations on · 6 of its ownK080132 THD Disposable Anoscope/ProctoscopeThd Spa · 2008
- Descendant · 3 generations on · 4 of its ownK091490 Family of THD Disposable Anoscopes/Proctoscopes/RectoscopesThd Spa · 2009
- Descendant · 4 generations on · 3 of its ownK103647 THD Disposable Anoscopes, Proctoscopes and RectoscopesThd Spa · 2011
- Descendant · 5 generations on · 1 of its ownK121135 THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-ScopeThd Spa · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K070913Self-Light Disposable AnoscopeSapimed S.P.A. · 2007 · cites it directly11descendants
- K080132THD Disposable Anoscope/ProctoscopeThd Spa · 2008 · 2 generations on6descendants
- K091490Family of THD Disposable Anoscopes/Proctoscopes/RectoscopesThd Spa · 2009 · 3 generations on4descendants
- K103647THD Disposable Anoscopes, Proctoscopes and RectoscopesThd Spa · 2011 · 4 generations on3descendants
- K121135THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-ScopeThd Spa · 2012 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993738 | Dispos-a-Scope | Dispos-A-Scope | 2000 | — |
| 0 (this device) | K020702 | O'regan Disposable Anoscope | Canadian Theatre Products, Ltd. | 2002 | — |
| +1 | K070913 | Self-Light Disposable Anoscope | Sapimed S.P.A. | 2007 | 1 |
| +2 | K080132 | THD Disposable Anoscope/Proctoscope | Thd Spa | 2008 | — |
| +3 | K091490 | Family of THD Disposable Anoscopes/Proctoscopes/Rectoscopes | Thd Spa | 2009 | — |
| +4 | K103647 | THD Disposable Anoscopes, Proctoscopes and Rectoscopes | Thd Spa | 2011 | — |
| +5 | K121135 | THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-Scope | Thd Spa | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 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 10.7 · 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 |
|---|---|---|---|
| * | K993738 | Dispos-a-ScopeSummary page 1…e Anoscope Classification Name: Class II Predicate Device Company Name: Dispos-A-Scope Proprietor Name: Dispos-A-Scope Common Name: Disposable Anoscope 510 (K) Number: K993738 Device Description: Similar to device’s marketed prior to or after May 28,1976 Intended Use: The O’Regan Disposable Anoscope is… | 2000 |
What descends from it? (13)
See all 132 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?
- Its one ancestor has no recall.
- Of its descendants, K070913 (Sapimed S.P.A., 2007) has gone furthest, with 11 descendants 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.
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 O’Regan Disposable Anoscope is 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020702: O'regan Disposable Anoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020702
Report an extraction error
Are you the manufacturer?
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