FDA product code · Microbiology

Gram Positive Identification Panel

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

LQLClass I21 CFR 866.2660510(k) exempt11 decisions since 19863 recalls

FDA lists LQL as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 11 FDA decisions since 1986. 3 recalls name this code, 0 of them Class I. The most-cited predicate is K910304, named by 1 later device.

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, microbiology panel

Twenty years of LQL 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 · LQL

FDA has decided no LQL device since 2007.

Median 510(k) review, days · LQL

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

Recalls per year · LQL

2in 2022

2007high 2 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LQL

23in 2025

2007high 89 (2017) · low 0 (2007)2025

MAUDE reports naming product code LQL, 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	—	0	0
2010	—	0	2
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	18
2016	—	0	35
2017	—	1	89
2018	—	0	70
2019	—	0	1
2020	—	0	3
2021	—	0	4
2022	—	2	6
2023	—	0	7
2024	—	0	5
2025	—	0	23
2026	—	0	—

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

Planning a device in LQL? 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

Related product codes

Other codes under 21 CFR 866.2660.

NZS Fish (Fluorescent In Situ Hybridization) Kit…JSR Kit, Identification, Dermatophyte OMN C. Difficile Nucleic Acid Amplification Test…JXC Kit, Screening, Yeast JWZ Kit, Screening, Trichomonas JSZ Kit, Identification, Pseudomonas JSP Kit, Anaerobic Identification JST Kit, Fastidious Organisms JSY Kit, Identification, Mycobacteria LQM Gram Negative Identification Panel MJM Dna Probe, Gardnerella Vaginalis LTS Test Reagents, Neisseria Gonorrhoeae Biochemical

Gram Positive Identification Panel

Which predicates do LQL devices cite most?

Which LQL devices have the deepest lineage?

What has FDA decided in LQL lately?

What has been recalled in LQL lately?

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