FDA product code · Hematology

Solution, Copper Sulfate For Specific Gravity Determinations

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

KSLClass I21 CFR 864.9320510(k) exempt2 decisions since 19810 recalls

FDA lists KSL as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 864.9 applies, such as a new intended use or a different fundamental technology. 2 FDA decisions since 1981. 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, hematology panel

Twenty years of KSL 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 · KSL

FDA has decided no KSL device since 2007.

Median 510(k) review, days · KSL

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

Recalls per year · KSL

No recall names KSL since 2007.

Adverse event reports per year · KSL

No MAUDE report names KSL 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 — KSL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KSL? 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

Solution, Copper Sulfate For Specific Gravity Determinations

What has FDA decided in KSL lately?