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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
25d faster than avg
Panel avg: 130d · 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 13
Devices cleared under the same product code (FEN) and FDA review panel - the closest regulatory comparables to K212830.
DANTEC DUET
K960503 · Dantec Medical, Inc. · Sep 1996
PVC ABDOMINAL/RECTAL PRESSURE CATHETER
K954315 · Life-Tech Intl., Inc. · Nov 1995
URODYNAMICS TUBING AND INFUSION SETS
K954341 · Life-Tech Intl., Inc. · Oct 1995
UROPUMP TUBE & DAMPING CHAMGER
K953451 · Life-Tech Intl., Inc. · Oct 1995
UROVISION JANUS
K953353 · Life-Tech Intl., Inc. · Sep 1995
RUSCH URODYNAMIC RECTAL BALLOON CATHETER
K952573 · Rusch Intl. · Jun 1995