510(k) · Cleared
ClearedDispos-a-Scope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dispos-A-Scope · FER Anoscope And Accessories
Cleared on Jan 6, 2000 after a 63-day review. The FDA summary names no predicate by number. 14 later devices descend from it.
- Decided
- Jan 6, 2000
- Review
- 63 days
- Class
- Class II
- Product code
- FER
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK993738 Dispos-a-ScopeDispos-A-Scope · 2000
- Descendant · cites it directly · 13 of its ownK020702 O'regan Disposable AnoscopeCanadian Theatre Products, Ltd. · 2002
- Descendant · 2 generations on · 11 of its ownK070913 Self-Light Disposable AnoscopeSapimed S.P.A. · 2007 · Recalled
- Descendant · 3 generations on · 6 of its ownK080132 THD Disposable Anoscope/ProctoscopeThd Spa · 2008
- Descendant · 4 generations on · 4 of its ownK091490 Family of THD Disposable Anoscopes/Proctoscopes/RectoscopesThd Spa · 2009
- Descendant · 5 generations on · 3 of its ownK103647 THD Disposable Anoscopes, Proctoscopes and RectoscopesThd Spa · 2011
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K020702O'regan Disposable AnoscopeCanadian Theatre Products, Ltd. · 2002 · cites it directly13descendants
- K070913Self-Light Disposable AnoscopeSapimed S.P.A. · 2007 · 2 generations on11descendants
- K080132THD Disposable Anoscope/ProctoscopeThd Spa · 2008 · 3 generations on6descendants
- K091490Family of THD Disposable Anoscopes/Proctoscopes/RectoscopesThd Spa · 2009 · 4 generations on4descendants
- K103647THD Disposable Anoscopes, Proctoscopes and RectoscopesThd Spa · 2011 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993738 | Dispos-a-Scope | Dispos-A-Scope | 2000 | — |
| +1 | K020702 | O'regan Disposable Anoscope | Canadian Theatre Products, Ltd. | 2002 | — |
| +2 | K070913 | Self-Light Disposable Anoscope | Sapimed S.P.A. | 2007 | 1 |
| +3 | K080132 | THD Disposable Anoscope/Proctoscope | Thd Spa | 2008 | — |
| +4 | K091490 | Family of THD Disposable Anoscopes/Proctoscopes/Rectoscopes | Thd Spa | 2009 | — |
| +5 | K103647 | THD Disposable Anoscopes, Proctoscopes and Rectoscopes | Thd Spa | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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 10.8 · 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?
The FDA summary names no predicate by number.
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020702 | O'regan Disposable Anoscope | 2002 | 13 |
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?
- Of its descendants, K020702 (Canadian Theatre Products, Ltd., 2002) has gone furthest, with 13 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 Dispos-A-Scope is intended for physician use enabling visual examination and certain treatment procedures involving the anal-rectal anatomy. The Dispos-A-Scope is 11cm long enabling visualization of the ano-rectal canal. The Dispos-A-Scope is constructed totally of a quasi-transparent resin. The resin has passed USP Class VI testing. The scope is designed for one time use and then disposal eliminating the risk of cross infection and nullifying the…
Read the full statement (145 words)
The Dispos-A-Scope is intended for physician use enabling visual examination and certain treatment procedures involving the anal-rectal anatomy.
The Dispos-A-Scope is 11cm long enabling visualization of the ano-rectal canal.
The Dispos-A-Scope is constructed totally of a quasi-transparent resin. The resin has passed USP Class VI testing. The scope is designed for one time use and then disposal eliminating the risk of cross infection and nullifying the need for sterilization of the instrument.
The Dispos-A-Scope is non-powered. It does not conduct electricity and is non-thermogenic.
The Dispos-A-Scope resin is quasi-compliant to external forces and will not crack or craze during normal usage.
The Dispos-A-Scope has an ergonomic handle facilitating accurate physician manipulation.
The Dispos-A-Scope has an operative port enabling precise isolation of tissue and pathology.
The Dispos-A-Scope has a replaceable obturator facilitating device insertion and rotation for precise operative port placement during examination and treatment 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/K993738 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993738: Dispos-a-Scope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993738
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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