FDA product code · Gastroenterology and urology

Dialyzer, Twin Coil

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

FJJClass II21 CFR 876.5820510(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, gastroenterology and urology panel

Twenty years of FJJ 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 — FJJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in FJJ? 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

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FLA Monitor, Temperature, Dialysis FJD Detector, Leak, Blood FLB Meter, Conductivity, Induction, Remote Type FIK System, Dialysate Delivery, Recirculating FID Tubing, Dialysate MSE Hemodialyzer, Re-Use, Low Flux MON System, Hemodialysis, Remote Accessories FKJ Filter, Blood, Dialysis FJF Detector, Air Bubble FIN Tank, Holding, Dialysis FIG Clamp, Tubing, Blood, Automatic FLC Station, Dialysis Control, Negative Pressure…