510(k) Report

FDA product code · General and plastic surgery

Implant, Collagen For Non-Aesthetic Use

LMIClass IIIPMA required0 decisions since 19850 recalls

0 FDA decisions since 1985. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general and plastic surgery panel

Twenty years of LMI at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · LMI

FDA has decided no LMI device since 2007.

Median 510(k) review, days · LMI

Too few LMI 510(k)s in any year since 2007 to give a median.

Recalls per year · LMI

No recall names LMI since 2007.

Adverse event reports per year · LMI

3in 2007

2007: 3
2007high 3 (2007) · low 0 (2008)2025

MAUDE reports naming product code LMI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — LMI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LMI? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report