FDA product code · Microbiology

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Name: FDA decisions, review times, recalls and adverse event reports for product code LOM
Creator: 510(k) Report

LOMClass II21 CFR 866.3172510(k) required26 decisions since 198026 recalls

26 FDA decisions since 1980. 26 recalls name this code, 0 of them Class I. The most-cited predicate is P190017, named by 1 later device.

In vitro diagnostic device intended for aid in the diagnosis of chronic or acute HBV infection. HBV surface antigen (HbsAg) is also used for screening of HBV infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during perinatal period.

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, microbiology panel

Twenty years of LOM 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 · LOM

68in 2025

2007high 125 (2012) · low 19 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LOM

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

Recalls per year · LOM

1in 2023

2007high 10 (2007) · low 0 (2011)2026

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

Adverse event reports per year · LOM

382in 2025

2007high 382 (2025) · low 64 (2008)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	19	—	10	72
2008	22	—	1	64
2009	48	—	2	128
2010	46	—	1	93
2011	119	—	0	132
2012	125	—	1	140
2013	46	—	2	174
2014	46	—	2	129
2015	38	—	0	139
2016	46	—	0	146
2017	57	—	0	88
2018	73	—	2	112
2019	36	—	0	191
2020	49	—	0	139
2021	57	—	0	147
2022	69	—	0	139
2023	63	—	1	163
2024	52	—	0	197
2025	68	—	0	382
2026	1	—	0	—

FIG. 1 — LOM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LOM? 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

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Which predicates do LOM devices cite most?

Which LOM devices have the deepest lineage?

What has FDA decided in LOM lately?

What has been recalled in LOM lately?