Cleared Traditional

REVIVE SYSTEM (K844445) - FDA 510(k) Clearance

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

K844445 · Revive Systems Corp. · Gastroenterology & Urology device
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Sep 1985
Decision
305d
Days
Class 2
Risk

K844445 is an FDA 510(k) clearance for the REVIVE SYSTEM. Classified as Device, External Penile Rigidity (product code LKY), Class II - Special Controls.

Submitted by Revive Systems Corp. (Washington, US). The FDA issued a Cleared decision on September 17, 1985 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5020 - 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. Elevated predicate reliance profile. 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 Revive Systems Corp. devices

Submission Details

510(k) Number K844445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1984
Decision Date September 17, 1985
Days to Decision 305 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 130d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKY Device, External Penile Rigidity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5020
Definition Intended To Create Or Maintain Sufficient Penile Rigidity For Sexual Intercourse. These Include Vacuum Pumps, Constriction Rings, And Penile Splints, Which Are Mechanical, Powered Or Pneumatic Devices.
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.