FDA product code · General and plastic surgery

Suture, Nonabsorable, Ophthalmic

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

HMNClass IIIPMA required1 decision since 19820 recalls

1 FDA decision since 1982. 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 HMN 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 · HMN

FDA has decided no HMN device since 2007.

Median 510(k) review, days · HMN

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

Recalls per year · HMN

No recall names HMN since 2007.

Adverse event reports per year · HMN

1in 2024

2007high 1 (2024) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	1
2025	—	0
2026	—	—

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

Planning a device in HMN? 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

Suture, Nonabsorable, Ophthalmic

What has FDA decided in HMN lately?