Cleared Traditional

K981852 - SILIMED TISSUE EXPANDER

K981852 · Silimed, LLC · General & Plastic Surgery device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Aug 1998

Decision

71d

Days

Risk

K981852 is an FDA 510(k) clearance for the SILIMED TISSUE EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Silimed, LLC (Crofton, US). The FDA issued a Cleared decision on August 5, 1998 after a review of 71 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 Silimed, LLC devices

FDA 510(k) Submission Details - K981852

510(k) Number	K981852 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 26, 1998
Decision Date	August 05, 1998
Days to Decision	71 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

44d faster than avg

Panel avg: 115d · This submission: 71d

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 25

Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K981852.

Natrelle 133 Plus Tissue Expander

K143354 · Allergan, Inc. · Aug 2015

MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS

K130813 · Mentor Corp. · Apr 2013

MENTOR CONTOUR PROFILE TISSUE EXPANDER

K011500 · Mentor Corp. · Dec 2001

MENTOR INJECTION PORT DETECTOR (IPD)

K963066 · Mentor Corp. · Sep 1996

ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT

K905484 · Mentor Corp. · Feb 1991

SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER

K903448 · Medical Engineering Corp. · Jan 1991

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 K981852

Silimed, LLC

Crofton, MD · US

E.J. Smith

Regulatory profile

9 submissions 9 cleared

100% 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 . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active