FDA product code · Clinical chemistry

Nephelometric, Amylase

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

KHMClass II21 CFR 862.1070510(k) required6 decisions since 19770 recalls

6 FDA decisions since 1977. 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 chemistry panel

Twenty years of KHM 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 · KHM

FDA has decided no KHM device since 2007.

Median 510(k) review, days · KHM

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

Recalls per year · KHM

No recall names KHM since 2007.

Adverse event reports per year · KHM

No MAUDE report names KHM since 2007.

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	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in KHM? 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 862.1070.

CIW Starch-Dye Bound Polymer, Amylase CJA Amyloclastic, Amylase CJD Nitrosalicylate Reduction, Amylase CIK Radial Diffusion, Amylase JFJ Catalytic Methods, Amylase CIJ Saccharogenic, Amylase

Nephelometric, Amylase

What has FDA decided in KHM lately?

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