# K770291: Sigmoidoscope, Disposable, Model #53125

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn, Inc.
- Decided: Feb 18, 1977 after 4 days
- Product code: FAM (Sigmoidoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K070915: Sapimed Disposable Sigmoidoscope (2007), 9 descendants of its own
- K080132: THD Disposable Anoscope/Proctoscope (2008), 6 descendants of its own
- K091490: Family of THD Disposable Anoscopes/Proctoscopes/Rectoscopes (2009), 4 descendants of its own
- K103647: THD Disposable Anoscopes, Proctoscopes and Rectoscopes (2011), 3 descendants of its own
- K133393: Gelpoint Path Transanal Access Platform (2014), 1 descendant of its own

Source page: https://510kreport.com/device/K770291
Methodology: https://510kreport.com/methodology