510(k) Report

FDA product code · General and plastic surgery

Agent, Absorbable Hemostatic, Collagen Based

LMFClass III21 CFR 878.4490PMA required10 decisions since 197620 recalls

10 FDA decisions since 1976. 20 recalls name this code, 2 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 LMF 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 · LMF

16in 2025

2007: 222008: 112009: 112010: 142011: 112012: 142013: 332014: 372015: 222016: 152017: 122018: 162019: 232020: 152021: 272022: 162023: 202024: 182025: 162026 (partial year): 15
2007high 37 (2014) · low 11 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LMF

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

Recalls per year · LMF

2in 2023

2008: 12012: 16, 2 Class I2023: 22026 (partial year): 1
2007high 16 (2012) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LMF

93in 2025

2007: 152008: 552009: 632010: 762011: 852012: 512013: 622014: 932015: 942016: 852017: 1212018: 1092019: 1512020: 1462021: 962022: 582023: 2712024: 1342025: 93
2007high 271 (2023) · low 15 (2007)2025

MAUDE reports naming product code LMF, 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
200722—015
200811—155
200911—063
201014—076
201111—085
201214—16 (2)51
201333—062
201437—093
201522—094
201615—085
201712—0121
201816—0109
201923—0151
202015—0146
202127—096
202216—058
202320—2271
202418—0134
202516—093
202615—1—
FIG. 1 — LMF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LMF? 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.