510(k) · Cleared
ClearedEos Brand Disposable Proctoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North Eos Industries, Inc. · GCP Endoscope, Ac-Powered And Accessories
Cleared on Apr 10, 1996 after a 188-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 12 later devices descend from it.
- Decided
- Apr 10, 1996
- Review
- 188 days
- Class
- Class II
- Product code
- GCP
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK954614 Eos Brand Disposable ProctoscopeNorth Eos Industries, Inc. · 1996
- 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 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K954614 | Eos Brand Disposable Proctoscope | North Eos Industries, Inc. | 1996 | — |
| +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 |
|---|---|---|
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GCP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070913 | Self-Light Disposable Anoscope | 2007 | 11 |
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, K070913 (Sapimed S.P.A., 2007) has gone furthest, with 11 descendants of its own.
How does its category compare?
All GCP devicesGCP Endoscope, Ac-Powered And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCP
FDA has decided no GCP device since 2007.
Median 510(k) review, days · GCP
Too few GCP 510(k)s in any year since 2007 to give a median.
Recalls per year · GCP
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GCP
180in 2025
MAUDE reports naming product code GCP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 13 |
| 2017 | 0 | — | 1 | 117 |
| 2018 | 0 | — | 0 | 26 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 26 |
| 2023 | 0 | — | 0 | 100 |
| 2024 | 0 | — | 1 | 108 |
| 2025 | 0 | — | 0 | 180 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K954614 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954614: Eos Brand Disposable Proctoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954614
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026