510(k) Report

FDA product code · General and plastic surgery

Agent, Absorbable Hemostatic, Non-Collagen Based

LMGClass III21 CFR 878.4490PMA required3 decisions since 19602 recalls

3 FDA decisions since 1960. 2 recalls name this code, 0 of them Class I.

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 LMG 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 · LMG

11in 2025

2007: 32008: 62010: 22011: 32012: 22013: 82014: 52015: 72016: 92017: 32018: 62019: 192020: 112021: 112022: 92023: 132024: 132025: 112026 (partial year): 8
2007high 19 (2019) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LMG

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

Recalls per year · LMG

2in 2025

2025: 2
2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LMG

229in 2025

2007: 22008: 42011: 102012: 302013: 602014: 62015: 22016: 22017: 302018: 842019: 1202020: 1732021: 2092022: 1442023: 2122024: 2332025: 229
2007high 233 (2024) · low 0 (2009)2025

MAUDE reports naming product code LMG, 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
20073—02
20086—04
20090—00
20102—00
20113—010
20122—030
20138—060
20145—06
20157—02
20169—02
20173—030
20186—084
201919—0120
202011—0173
202111—0209
20229—0144
202313—0212
202413—0233
202511—2229
20268—0—
FIG. 1 — LMG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LMG? 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

Related product codes

Other codes under 21 CFR 878.4490.