Cleared Special

K202286 - Tulsa-Pro System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K202286 · Profound Medical, Inc. · Gastroenterology & Urology device
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Sep 2020
Decision
35d
Days
Class 2
Risk

K202286 is an FDA 510(k) clearance for the Tulsa-Pro System. Classified as High Intensity Ultrasound System For Prostate Tissue Ablation (product code PLP), Class II - Special Controls.

Submitted by Profound Medical, Inc. (Mississauga, CA). The FDA issued a Cleared decision on September 16, 2020 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4340 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Profound Medical, Inc. devices

Submission Details

510(k) Number K202286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2020
Decision Date September 16, 2020
Days to Decision 35 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 130d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PLP High Intensity Ultrasound System For Prostate Tissue Ablation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4340
Definition Prostate Tissue Ablation
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 - PLP High Intensity Ultrasound System For Prostate Tissue Ablation

All 12
Devices cleared under the same product code (PLP) and FDA review panel - the closest regulatory comparables to K202286.
Focal One®
K251910 · Edap Technomed, Inc. · Nov 2025
Tulsa Pro System (Pad-105)
K240296 · Profound Medical, Inc. · May 2024
Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0
K231378 · Insightec , Ltd. · Oct 2023
TULSA-PRO System
K230692 · Profound Medical, Inc. · Sep 2023
TULSA-PRO System
K211858 · Profound Medical, Inc. · Sep 2022
Exablate Prostate System
K212150 · InSightec, Inc. · Nov 2021