Cleared Traditional

K854794 - MCGHAN INTEGRAL VALVE TISSUE EXPANDER

K854794 · Mcghan Medical Corp. · General & Plastic Surgery device

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Dec 1985

Decision

22d

Days

Risk

K854794 is an FDA 510(k) clearance for the MCGHAN INTEGRAL VALVE TISSUE EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Mcghan Medical Corp. (Santa Barbara, US). The FDA issued a Cleared decision on December 24, 1985 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Mcghan Medical Corp. devices

Submission Details

510(k) Number	K854794 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 02, 1985
Decision Date	December 24, 1985
Days to Decision	22 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

93d faster than avg

Panel avg: 115d · This submission: 22d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	LCJ Tissue Expander And Accessories
Device Class	-

Regulatory Peers - LCJ Tissue Expander And Accessories

All 20

Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K854794.

MENTOR TISSUE EXPANDERS W/TDMAC COATING

K894475 · Mentor Corp. · Nov 1990

RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)

K884250 · Mentor Corp. · Jun 1989

MENTOR FLAT-SPAN

K862049 · Mentor Corp. · Jun 1986

MENTOR EXPANDER MAMMARY PROSTHESIS

K844813 · Mentor Corp. · May 1985

RADOVAN TISSUE EXPANDER

K842883 · Mentor Corp. · Aug 1984

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K854794

Mcghan Medical Corp.

Santa Barbara, CA · US

LAURENS LICHTY

Regulatory profile

14 submissions 14 cleared

100% clearance rate · Active in General & Plastic Surgery

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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