FDA product code · General hospital

Syringe, Piston, Reprocessed

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

NKNClass II21 CFR 880.5860510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body. Reprocessing validation data for this device type must be included in a 510(k)…

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 NKN 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 · NKN

FDA has decided no NKN device since 2007.

Median 510(k) review, days · NKN

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

Recalls per year · NKN

No recall names NKN since 2007.

Adverse event reports per year · NKN

1in 2016

2007high 1 (2012) · low 0 (2007)2025

MAUDE reports naming product code NKN, 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	—	1
2013	—	0
2014	—	0
2015	—	0
2016	—	1
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in NKN? 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 880.5860.

QOG Injection Data Capture Device MZM Fibrin Sealant Preparation Device QLF On-Body Injector FMF Syringe, Piston NSC Injector, Pen QLY Ophthalmic Syringe QBL Piston Syringe Lever PQX Epinephrine Syringe QEH Piston Syringe With Neuraxial Connector –…QNQ Low Dead Space Piston Syringe PUR Vacuum Syringe MEG Syringe, Antistick