Cleared Traditional

K011435 - HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM

K011435 is an FDA 510(k) clearance for HMT 21, manufactured by Hmt, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K011435 · Hmt, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
43d
Days
Class 2
Risk

K011435 is an FDA 510(k) clearance for the HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Hmt, Inc. (Seoul, KR). The FDA issued a Cleared decision on June 22, 2001 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5320 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hmt, Inc. devices

FDA 510(k) Submission Details - K011435

510(k) Number K011435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2001
Decision Date June 22, 2001
Days to Decision 43 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 131d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KPI Device Classification - Class 2, Special Controls

Product Code KPI Stimulator, Electrical, Non-implantable, For Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5320
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

Underwriters Laboratories, Inc.

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.

Regulatory Peers - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 87
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K011435.
SKYLARK URO PROBE
K053007 · Skylark Device & Systems Co., Ltd. · Dec 2005
EVADRI BLADDER CONTROL SYSTEMS
K050483 · Hollister, Inc. · Apr 2005
MICROGYN PLUS STIMULATION DEVICE
K013141 · Hollister, Inc. · Dec 2001
K.E.A.T.
K002154 · Emd Electronic Medical Devices, Corp. · Mar 2001
NEOCONTROL PELVIC FLOOR THERAPY SYSTEM
K001903 · Neotonus, Inc. · Aug 2000
DETRUSAN 500
K994109 · Innovamed USA, Inc. · Aug 2000

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.