Model note · Urodynamics System
SRS Medical CT3000Pro urodynamics system
The CT3000Pro is an office and hospital urodynamics system from SRS Medical. A console works with an all in one touch screen PC, a urine scale and an infusion pump to run catheter based studies, uroflow and a non-invasive test. The non-invasive mode uses the UroCuff, a penile cuff that inflates during voiding until flow is interrupted, so bladder pressure can be estimated without a catheter. It was cleared by the FDA in December 2021 with the Laborie Urodynamics System with Tetra as predicate.
The model
Maker, model and type.
- Maker
- SRS Medical (North Billerica, Massachusetts)
- Model
- CT3000Pro urodynamics system
- Device type
- Urodynamics System
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Test types | Catheterised urodynamics, non-invasive urodynamics with UroCuff, and uroflow | Source |
| Pressure channels (catheterised mode) | Up to three, from one or two catheters (vesical and optional abdominal) | Source |
| Pressure range | 0 to 215 cmH2O | Source |
| Uroflow rate range | 0 to 50 ml/s (same as predicate) | Source |
| Uroflow volume range | 0 to 1500 ml | Source |
| Infusion pump rate | 0 to 100 ml/min; infused volume 0 to 1000 ml | Source |
| Surface EMG | Two channels, 225 uV, 20 to 500 Hz | Source |
| Electrical class and ingress rating | Class I equipment, IPX0, continuous operation (same as predicate) | Source |
| PC link and storage | USB connection to the PC; data stored on the local PC hard disk | Source |
| FDA clearance | K212830, regulation 21 CFR 876.1620, Class II, product codes FEN and EXQ, decided 21 December 2021 | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- The console is rated IPX0, so it has no stated protection against water ingress; keep voided urine and infusion fluid away from it. Source
- Apart from the UroCuff-DC, patient contacting parts come from third party makers; use only the registered parts SRS specifies. Source
- Contrast medium or very concentrated urine is denser than water, so a scale set to 1 g/ml will over read flow and volume unless density is set correctly. Source
- The system is intended for use under the direction of a licensed physician or healthcare professional in an office or hospital. Source
Sources
Where this note comes from.
- FDA 510(k) K212830 summary, SRS Medical CT3000Pro
- SRS Medical, The UroCuff Test for healthcare professionals
- SRS Medical products page
- Gammie et al., ICS Guidelines on Urodynamic Equipment Performance, Neurourol Urodyn 2014
- NHS Centre for Evidence-based Purchasing, Urodynamic systems evaluation report CEP09038 (2009)
- openFDA recall search, SRS Medical
Not covered: No CT3000Pro operator or service manual is publicly available from SRS Medical, so there are no error codes, part numbers or device specific calibration steps; first checks and failing parts come from general ICS and NHS urodynamic guidance and should be checked against the SRS manual. Pressure and pump ranges are taken from the 510(k) comparison table; the summary states the applied part type as 'BE', which looks like a typo and is left out. No FDA recalls were found for SRS Medical. MAUDE returned only 8 reports for SRS Medical as a whole, all coded as adverse events without an identified device problem, and they may relate to other SRS products, so no trend is drawn. Swapped from the Goby system, which is now marketed by Laborie, the same maker as the existing flagship note.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Urodynamics System
Other models of this device.
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