Cleared Traditional

K210138 - iTind System (FDA 510(k) Clearance)

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

K210138 · Medi-Tate , Ltd. · Gastroenterology & Urology device
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Jun 2021
Decision
157d
Days
Class 2
Risk

K210138 is an FDA 510(k) clearance for the iTind System. Classified as Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia (product code QKA), Class II - Special Controls.

Submitted by Medi-Tate , Ltd. (Hadera, IL). The FDA issued a Cleared decision on June 25, 2021 after a review of 157 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5510 - 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 Medi-Tate , Ltd. devices

Submission Details

510(k) Number K210138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2021
Decision Date June 25, 2021
Days to Decision 157 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
27d slower than avg
Panel avg: 130d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QKA Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5510
Definition A System Intended For The Treatment Of Symptoms Due To Urinary Outflow Obstruction Secondary To Benign Prostatic Hyperplasia (bph) In Men Age 50 And Above.
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 Consultant

Hogan Lovells US LLP
Janice M. Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.