FDA product code · General and plastic surgery

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

LRRClass N15 decisions since 198413 recalls

15 FDA decisions since 1984. 13 recalls name this code, 1 of them Class I.

Note: In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well. www.fda.gov/cder/index.html - This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of…

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 LRR 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 · LRR

FDA has decided no LRR device since 2007.

Median 510(k) review, days · LRR

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

Recalls per year · LRR

2in 2022

2007high 5 (2011) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · LRR

2in 2025

2007high 2 (2014) · low 0 (2007)2025

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

View these four charts as a table

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

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

Planning a device in LRR? 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

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Which LRR devices have the deepest lineage?

What has FDA decided in LRR lately?

What has been recalled in LRR lately?