FDA product code · Gastroenterology and urology

System, Dialysate Delivery, Recirculating

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

FIKClass 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 FIK 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 — FIK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in FIK? 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 876.5820.

FLA Monitor, Temperature, Dialysis FJD Detector, Leak, Blood FLB Meter, Conductivity, Induction, Remote Type 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…FJJ Dialyzer, Twin Coil