# K212830: CT3000Pro

- Pathway: 510(k) (Traditional)
- Applicant: Srs Medical
- Decided: Dec 21, 2021 after 105 days
- Product code: FEN (Device, Cystometric, Hydraulic)
- Device class: 2
- Regulation: 21 CFR 876.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931574 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073552: Laborie Urodynamic System with Tetra Accessory, Laborie Medical Technologies, Corp. (2008) Summary page 4.

## Indications for use
The CT3000Pro is intended for urodynamic testing. The equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The non-invasive option utilizes a penile cuff (UroCuff-Classic or UroCuff-DC) for non-invasive testing of bladder activity, by assessing the pressure necessary to interrupt urine flow. The CT3000Pro is intended for use under the direction of a licensed physician or health care professional in an office or hospital setting.

Source page: https://510kreport.com/device/K212830
Methodology: https://510kreport.com/methodology