Cleared Traditional

K211858 - TULSA-PRO System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211858 · Profound Medical, Inc. · Gastroenterology & Urology device
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Sep 2022
Decision
447d
Days
Class 2
Risk

K211858 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 6, 2022 after a review of 447 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4340 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Profound Medical, Inc. devices

Submission Details

510(k) Number K211858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2021
Decision Date September 06, 2022
Days to Decision 447 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
317d slower than avg
Panel avg: 130d · This submission: 447d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K211858.
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
Exablate Prostate System
K212150 · InSightec, Inc. · Nov 2021