FDA product code · General hospital

On-Body Injector

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

QLFClass II21 CFR 880.5860Pathway set case by case0 decisions0 recalls

0 FDA decisions. No recall names this code.

An On-Body injector is a prescription device adhered to the body intended to inject single or multiple doses of medicinal product from a cartridge or reservoir in accordance with FDA approved labeling. The device can be used by health care professionals or for self-injection by the patient. It should not be used for the infusion of drugs.

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 QLF 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.

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

Planning a device in QLF? 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 FMF Syringe, Piston NSC Injector, Pen QLY Ophthalmic Syringe QBL Piston Syringe Lever NKN Syringe, Piston, Reprocessed PQX Epinephrine Syringe QEH Piston Syringe With Neuraxial Connector –…QNQ Low Dead Space Piston Syringe PUR Vacuum Syringe MEG Syringe, Antistick