FDA product code · General and plastic surgery

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

LRSClass II21 CFR 880.520030 decisions since 1976127 recalls

30 FDA decisions since 1976. 127 recalls name this code, 4 of them Class I.

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if…

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 LRS 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 · LRS

FDA has decided no LRS device since 2007.

Median 510(k) review, days · LRS

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

Recalls per year · LRS

1in 2025

2007high 61 (2011) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · LRS

34in 2025

2007high 34 (2023) · low 0 (2007)2025

MAUDE reports naming product code LRS, 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	—	0	0
2008	—	0	1
2009	—	7	4
2010	—	29	2
2011	—	61	1
2012	—	0	8
2013	—	0	12
2014	—	0	6
2015	—	0	6
2016	—	1	8
2017	—	1	3
2018	—	0	5
2019	—	7	11
2020	—	0	7
2021	—	0	7
2022	—	7	7
2023	—	0	34
2024	—	1	20
2025	—	1	34
2026	—	12 (4)	—

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

Planning a device in LRS? 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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