FDA product code · General hospital

Infusion Pump, Drug Specific, Pharmacy-Filled

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

QJYClass II21 CFR 880.5725510(k) required4 decisions since 20200 recalls

4 FDA decisions since 2020. 510(k) reviews decided 2021–2025 took a median of 81 days (half between 55 and 107). No recall names this code. The most-cited predicate is K191313, named by 2 later devices.

A Pharmacy-Filled, Drug Specific Infusion System is a prescription device intended for delivery of a specific drug in accordance with the FDA approved labeling and may be filled at a location other than point of care.

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 QJY 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 · QJY

2in 2024

2007high 2 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QJY

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

Recalls per year · QJY

No recall names QJY since 2007.

Adverse event reports per year · QJY

154in 2025

2007high 154 (2025) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	2	—	0
2021	0	—	4
2022	0	—	22
2023	0	—	61
2024	2	—	43
2025	0	—	154
2026	0	—	—

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

Planning a device in QJY? 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 880.5725.

PMS Peripheral Intravenous (Piv) Infiltration…MEA Pump, Infusion, Pca PHC Infusion Safety Management Software MEB Pump, Infusion, Elastomeric PKP Immunoglobulin G (Igg) Infusion System LZG Pump, Infusion, Insulin LHF Warmer, Microwave, Infusion Fluid LDR Controller, Infusion, Intravascular, Electronic LZH Pump, Infusion, Enteral FRN Pump, Infusion MRZ Accessories, Pump, Infusion MRH Pump, Infusion, Ophthalmic

Infusion Pump, Drug Specific, Pharmacy-Filled

Which predicates do QJY devices cite most?

Which QJY devices have the deepest lineage?

What has FDA decided in QJY lately?

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