FDA product code · General and plastic surgery

Pad, Eye

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

HMPClass I21 CFR 878.4440510(k) exempt17 decisions since 19780 recalls

FDA lists HMP as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 878.9 applies, such as a new intended use or a different fundamental technology. 17 FDA decisions since 1978. 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 HMP 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 · HMP

FDA has decided no HMP device since 2007.

Median 510(k) review, days · HMP

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

Recalls per year · HMP

No recall names HMP since 2007.

Adverse event reports per year · HMP

8in 2017

2007high 8 (2017) · low 0 (2007)2025

MAUDE reports naming product code HMP, 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	—	8
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in HMP? 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

Pad, Eye

What has FDA decided in HMP lately?