Cleared Traditional

K212830 - CT3000Pro

K212830 is an FDA 510(k) clearance for CT3000Pro, manufactured by Srs Medical. The device is a Class 2 Gastroenterology & Urology device with product code FEN cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K212830 · Srs Medical · Gastroenterology & Urology device
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Dec 2021
Decision
105d
Days
Class 2
Risk

K212830 is an FDA 510(k) clearance for the CT3000Pro. Classified as Device, Cystometric, Hydraulic (product code FEN), Class II - Special Controls.

Submitted by Srs Medical (North Billerica, US). The FDA issued a Cleared decision on December 21, 2021 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Srs Medical devices

FDA 510(k) Submission Details - K212830

510(k) Number K212830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2021
Decision Date December 21, 2021
Days to Decision 105 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 131d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEN Device Classification - Class 2, Special Controls

Product Code FEN Device, Cystometric, Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FEN Device, Cystometric, Hydraulic

All 23
Devices cleared under the same product code (FEN) and FDA review panel - the closest regulatory comparables to K212830.
URONIRS, MODEL 2000
K082701 · Urodynamix Technologies, Ltd. · Dec 2008
LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY
K073552 · Laborie Medical Technologies, Corp. · Mar 2008
ACCUSET SENSOR, MODEL 2000
K001386 · Pelvicare, Inc. · Jul 2000
NEURO URODYNAMIC SUITE, MODEL 9032E0101
K992715 · Medtronic Functional Diagnostics A/S · Feb 2000
IN-PROBE II URODYNAMIC SYSTEM
K983325 · Influence, Inc. · Nov 1998
CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP
K970595 · Circon Video · Oct 1997