# K251140: Zenflow Spring Scope

- Pathway: 510(k) (Traditional)
- Applicant: Zenflow, Inc.
- Decided: Sep 23, 2025 after 162 days
- Product code: FAJ (Cystoscope 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
Longest line of descent: 10 generations back to K921244 (1992). 44 ancestors in all.
No later device cites it as a predicate yet.
2 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193095: Ambu aScope 4 Cysto, Ambu A/S (2020) Summary page 5.

## Indications for use
The Zenflow Spring Scope is a sterile, single use flexible cystoscope intended to provide endoscopic access and visualization of the lower urinary tract. The Zenflow Spring Scope is intended for use with the separately provided Zenflow Camera Control Unit and which provides visualization via any commercially compatible video monitor. The Zenflow Spring Scope can be used with compatible endoscopic accessories. The Zenflow Spring Scope is intended for use in a hospital environment or medical office environment. The Zenflow Spring Scope is designed for use in adults.

Source page: https://510kreport.com/device/K251140
Methodology: https://510kreport.com/methodology