FDA product code · Clinical toxicology

Amikacin Serum Assay

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

KLPClass II21 CFR 862.3035510(k) required4 decisions since 19780 recalls

4 FDA decisions since 1978. No recall names this code.

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 KLP 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 · KLP

FDA has decided no KLP device since 2007.

Median 510(k) review, days · KLP

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

Recalls per year · KLP

No recall names KLP since 2007.

Adverse event reports per year · KLP

2in 2023

2007high 2 (2023) · low 0 (2007)2025

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

View these four charts as a table

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

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

Planning a device in KLP? 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 862.3035.

LDN Enzymatic Radiochemical Assay, Amikacin KLQ Radioimmunoassay, Amikacin LGJ Fluorescence Polarization Immunoassay, Amibacin

Amikacin Serum Assay

Which KLP devices have the deepest lineage?

What has FDA decided in KLP lately?

Related product codes