FDA product code · Clinical chemistry

Chromium-51, Blood Volume

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

JKPClass I21 CFR 862.1130510(k) exempt1 decision since 19810 recalls

FDA lists JKP as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision 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, clinical chemistry panel

Twenty years of JKP 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 · JKP

FDA has decided no JKP device since 2007.

Median 510(k) review, days · JKP

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

Recalls per year · JKP

No recall names JKP since 2007.

Adverse event reports per year · JKP

1in 2015

2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code JKP, 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	—	1
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in JKP? 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

Chromium-51, Blood Volume

What has FDA decided in JKP lately?