Cleared Traditional

K935213 - INCONTROL

K935213 is an FDA 510(k) clearance for INCONTROL, manufactured by Thought Technology , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code HIR cleared through the Traditional 510(k) pathway after a 559-day FDA review.

K935213 · Thought Technology , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
559d
Days
Class 2
Risk

K935213 is an FDA 510(k) clearance for the INCONTROL. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Thought Technology , Ltd. (Montreal, Quebec, CA). The FDA issued a Cleared decision on May 11, 1995 after a review of 559 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 884.1425 - 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 Thought Technology , Ltd. devices

FDA 510(k) Submission Details - K935213

510(k) Number K935213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1993
Decision Date May 11, 1995
Days to Decision 559 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
428d slower than avg
Panel avg: 131d · This submission: 559d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIR Device Classification - Class 2, Special Controls

Product Code HIR Perineometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1425
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 - HIR Perineometer

All 42
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K935213.
INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE
K952688 · Empi · Dec 1995
MYOTRAC2D/CS
K925681 · Thought Technology , Ltd. · Sep 1995
THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE
K932149 · Thought Technology , Ltd. · May 1995
INNOVA VAGINAL EMG SENSING ELECTRODE
K940091 · Empi · Dec 1994
EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE)
K926218 · Sandhill Scientific, Inc. · Aug 1994
EXTACISER PERINEAL MUSCLE EXERCISER
K892888 · Bivona Medical Technologies · Oct 1989