# K911278: Olympus AF Angioscope System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corp.
- Decided: Jul 17, 1991 after 114 days
- Product code: LYK (Angioscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 4 cite it directly.
0 of 11 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
- K070752: Ksea Miniature Endoscope, Model 11565 (2007), 6 descendants of its own
- K082569: Entellus Medical Flexible Endoscope and Eyepiece (2008), 5 descendants of its own
- K162916: 3NT endoscopy system (2017), 3 descendants of its own
- K050808: Coronary Sinus Access Kit, Model KCS8F-01 (2005), 1 descendant of its own
- K251767: Vena MicroAngioscope™ System (2025), 0 descendants of its own

## Recalls of this device
- Sep 25, 2023 · Class III · Z-0330-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten

Source page: https://510kreport.com/device/K911278
Methodology: https://510kreport.com/methodology