510(k) Report

FDA product code · General hospital

Injector, Contrast Medium, Automatic, Reprocessed

NKPClass II21 CFR 870.1650510(k) required0 decisions0 recalls

0 FDA decisions. 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, general hospital panel

Twenty years of NKP 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 · NKP

FDA has decided no NKP device since 2007.

Median 510(k) review, days · NKP

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

Recalls per year · NKP

No recall names NKP since 2007.

Adverse event reports per year · NKP

1in 2025

2012: 12016: 12025: 1
2007high 1 (2012) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—01
20130—00
20140—00
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—
FIG. 1 — NKP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NKP? 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 870.1650.