FDA product code · Clinical toxicology

Radioimmunoassay, Tobramycin

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

KLBClass II21 CFR 862.3900510(k) required23 decisions since 19762 recalls

23 FDA decisions since 1976. 2 recalls name this code, 0 of them Class I. The most-cited predicate is K003341, 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, clinical toxicology panel

Twenty years of KLB 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 · KLB

FDA has decided no KLB device since 2007.

Median 510(k) review, days · KLB

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

Recalls per year · KLB

2in 2007

2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KLB

1in 2024

2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code KLB, 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	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	1
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	1
2025	—	0	0
2026	—	0	—

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

Planning a device in KLB? 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 862.3900.

LDO Enzymatic Radiochemical Assay, Tobramycin KZX Kit, Disc, Agar Gel Diffusion, Determine Serum…DID Bacillus Subtilis Microbiology Assay, Tobramycin LFW Fluorescence Polarization Immunoassay…LCR Fluorescent Immunoassay, Tobramycin

Radioimmunoassay, Tobramycin

Which predicates do KLB devices cite most?

Which KLB devices have the deepest lineage?

What has FDA decided in KLB lately?

What has been recalled in KLB lately?

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