510(k) Report

FDA applicant

Icor AB

Bromma, SE16 decisions1986–19960 recalls

FDA records 16 decisions for Icor AB (Bromma, SE) from 1986 to 1996: 16 510(k) clearances. Most are in product codes BYD (Condenser, Heat And Moisture (Artificial Nose)) and BZL (Computer, Oxygen-Uptake). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Icor AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Icor AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Icor AB’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report