Cleared Traditional

K840464 - TISSUE EXPANDER

K840464 · Surgitek · General & Plastic Surgery device

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Mar 1984

Decision

38d

Days

Risk

K840464 is an FDA 510(k) clearance for the TISSUE EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Surgitek (Mchenry, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 38 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 Surgitek devices

FDA 510(k) Submission Details - K840464

510(k) Number	K840464 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 03, 1984
Decision Date	March 12, 1984
Days to Decision	38 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

77d faster than avg

Panel avg: 115d · This submission: 38d

Pathway characteristics

Predicate-based equivalence.

LCJ Device Classification - Class 0,

Product Code	LCJ Tissue Expander And Accessories
Device Class	-

Regulatory Peers - LCJ Tissue Expander And Accessories

All 26

Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K840464.

TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600

K845036 · Progress Mankind Technology · Jun 1985

MENTOR EXPANDER MAMMARY PROSTHESIS

K844813 · Mentor Corp. · May 1985

RADOVAN TISSUE EXPANDER

K842883 · Mentor Corp. · Aug 1984

SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE

K801042 · Dow Corning Corp. Healthcare Industries Materials · Jun 1980

FDA 510(k) Resources - General & Plastic Surgery

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

Manufacturer of K840464

Surgitek

Mchenry, IL · US

Regulatory profile

29 submissions 28 cleared

97% clearance rate · Active in General & Plastic Surgery

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

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 . FDA decision: March 12, 1984. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

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