FDA product code · General and plastic surgery

Leeches, Medicinal

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

NRNClass U510(k) required3 decisions since 20040 recalls

3 FDA decisions since 2004. No recall names this code. The most-cited predicate is K040187, named by 2 later devices.

The device is a medicinal leech (hirudo medicinalis) belonging to the annelida worm classification. The animal is a bloodsucking aquatic animal living in fresh water. The device should be indicated as: "an adjunct to the graft tissue healing when problems of venous congestion may delay healing, or to overcome the problem of venous congestion by creating prolonged localized bleeding." See Federal Register Notice at…

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 NRN 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 · NRN

1in 2015

2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NRN

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

Recalls per year · NRN

No recall names NRN since 2007.

Adverse event reports per year · NRN

5in 2025

2007high 5 (2024) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	3
2013	0	—	2
2014	1	—	0
2015	1	—	4
2016	0	—	4
2017	0	—	2
2018	0	—	4
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	4
2024	0	—	5
2025	0	—	5
2026	0	—	—

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

Planning a device in NRN? 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

Leeches, Medicinal

Which predicates do NRN devices cite most?

Which NRN devices have the deepest lineage?

What has FDA decided in NRN lately?