510(k) · Cleared
ClearedSigmoidoscope, Disposable, Model #53125
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · FAM Sigmoidoscope And Accessories, Flexible/Rigid
Cleared on Feb 18, 1977 after a 4-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Feb 18, 1977
- Review
- 4 days
- Class
- Class II
- Product code
- FAM
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 3 citing it directly.
- This deviceK770291 Sigmoidoscope, Disposable, Model #53125Welch Allyn, Inc. · 1977
- Descendant · cites it directly · 9 of its ownK070915 Sapimed Disposable SigmoidoscopeSapimed 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 · 2 generations on · 1 of its ownK133393 Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp. · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K070915Sapimed Disposable SigmoidoscopeSapimed S.P.A. · 2007 · cites it directly9descendants
- 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
- K133393Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp. · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K770291 | Sigmoidoscope, Disposable, Model #53125 | Welch Allyn, Inc. | 1977 | — |
| +1 | K070915 | Sapimed Disposable Sigmoidoscope | 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 | — |
| +2 | K133393 | Gelpoint Path Transanal Access Platform | Applied Medical Resources Corp. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 2 | 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 FAM? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 123 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?
- Of its descendants, K070915 (Sapimed S.P.A., 2007) has gone furthest, with 9 descendants of its own.
How does its category compare?
All FAM devicesFAM Sigmoidoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAM
FDA has decided no FAM device since 2007.
Median 510(k) review, days · FAM
Too few FAM 510(k)s in any year since 2007 to give a median.
Recalls per year · FAM
No recall names FAM since 2007.
Adverse event reports per year · FAM
3in 2025
MAUDE reports naming product code FAM, 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 | 2 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K770291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K770291: Sigmoidoscope, Disposable, Model #53125.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K770291
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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