510(k) Report

FDA applicant

Artema Medical AB

Sweden, SE5 decisions1991–19950 recalls

FDA records 5 decisions for Artema Medical AB (Sweden, SE) from 1991 to 1995: 5 510(k) clearances. All are in product code BYD (Condenser, Heat And Moisture (Artificial Nose)). 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 Artema Medical AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Artema Medical AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Artema Medical 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

Which product codes does it file in?

  • BYDCondenser, Heat And Moisture (Artificial Nose)5decisions

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K945359Aqua+I-F, I-H, I-FH, II-H, II-FH, Iii-HArtema Medical AB · 19951cites it

What has FDA decided for it lately?

  • K945359Aqua+I-F, I-H, I-FH, II-H, II-FH, Iii-HArtema Medical AB · 1995
  • K912333Artema Aqua+Artema Medical AB · 1991
  • K912336Artema Aqua+ FlexArtema Medical AB · 1991
  • K912335Artema Aqua+ NArtema Medical AB · 1991
  • K912334Artema Aqua+ T & TSArtema Medical AB · 1991

All 5 as Artema Medical AB →