# K914008: Pentax Cystofiberscope, Model Fcy-15P

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Jan 10, 1992 after 123 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- 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.
27 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K040215: Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System (2004), 26 descendants of its own
- K053560: Modified Endosheath System for Vsi Flexible Cystoscope (2006), 23 descendants of its own
- K072180: Vision-Sciences CST-5000 Video Cystoscope with Endosheath System (2007), 20 descendants of its own
- K160766: Ambu USR, Ambu M (2016), 14 descendants of its own
- K193095: Ambu aScope 4 Cysto (2020), 13 descendants of its own

## Recalls of this device
- Apr 6, 2016 · Class II · Z-2070-2016: Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Source page: https://510kreport.com/device/K914008
Methodology: https://510kreport.com/methodology