Cleared Traditional

FIRM MASTER (K905195) - FDA 510(k) Clearance

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

K905195 · Bak Medical Products · Toxicology device
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Feb 1991
Decision
74d
Days
Class 2
Risk

K905195 is an FDA 510(k) clearance for the FIRM MASTER. Classified as Device, External Penile Rigidity (product code LKY), Class II - Special Controls.

Submitted by Bak Medical Products (Martinez, US). The FDA issued a Cleared decision on February 1, 1991 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 876.5020 - the FDA toxicology 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.

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Submission Details

510(k) Number K905195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1990
Decision Date February 01, 1991
Days to Decision 74 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 87d · This submission: 74d
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 Toxicology devices follow this clearance model.