Cleared Traditional

K220760 - Pre-Formed Penile Silicone Block (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K220760 · International Medical Devices, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
59d
Days
Class 2
Risk

K220760 is an FDA 510(k) clearance for the Pre-Formed Penile Silicone Block. Classified as Elastomer, Silicone Block (product code MIB), Class II - Special Controls.

Submitted by International Medical Devices, Inc. (Beverly Hills, US). The FDA issued a Cleared decision on May 13, 2022 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 874.3620 - the FDA general and plastic surgery 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 International Medical Devices, Inc. devices

Submission Details

510(k) Number K220760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2022
Decision Date May 13, 2022
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 114d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MIB Elastomer, Silicone Block
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

RQM+
Allison Komiyama

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.

Clinical Evidence

ClinicalTrials.gov
NCT02477189 Completed Observational Industry-sponsored

Retrospective Analysis of the Safety and Effectiveness of Using the Silicone Block in Penile Surgery

400
Patients (actual)
1
Site
Condition studied Penile Implant
Eligibility Male only · 18 Years+
Sponsor International Medical Devices, Inc. (industry)
Started 2015-04-01 → Primary completion 2015-05-01
Primary outcome
Number of Adverse Events
Secondary outcome
Self-Esteem Score
Study completed - no results published. This trial concluded in 2015 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov