Cleared Traditional

K994079 - REFLEX TREATMENT SYSTEM

K994079 is an FDA 510(k) clearance for REFLEX TREATMENT SYSTEM, manufactured by Deschutes Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code HIR cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K994079 · Deschutes Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
90d
Days
Class 2
Risk

K994079 is an FDA 510(k) clearance for the REFLEX TREATMENT SYSTEM. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Deschutes Medical Products, Inc. (Bend, US). The FDA issued a Cleared decision on March 1, 2000 after a review of 90 days - within the typical 510(k) review window.

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: 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 Deschutes Medical Products, Inc. devices

FDA 510(k) Submission Details - K994079

510(k) Number K994079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1999
Decision Date March 01, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
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 22
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K994079.
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PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)
K970145 · Biosearch Medical Products, Inc. · Aug 1997
PERINEOMETER
K960311 · Hollister, Inc. · Apr 1996
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K952688 · Empi · Dec 1995