510(k) Report

FDA applicant

Ardo Medical AG

Unteraegeri, CH6 decisions2001–20230 recalls

FDA records 6 decisions for Ardo Medical AG (Unteraegeri, CH) from 2001 to 2023: 6 510(k) clearances. Most are in product codes HGX (Pump, Breast, Powered) and BTA (Pump, Portable, Aspiration (Manual Or Powered)). Since 2016 its 510(k)s took a median of 145 days from receipt to decision, against 167 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 3 of them its own earlier devices. 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Ardo Medical AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2014: 12015: 12017: 12022: 12023: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ardo Medical AG’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?

  • HGXPump, Breast, Powered5decisions
  • BTAPump, Portable, Aspiration (Manual Or Powered)1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 145 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 167 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K141742Ardo Carum and Calypso Powered Breast PumpsArdo Medical AG · 20143cite it
  • K212773ARDO AlyssaArdo Medical AG · 20221cites it

What has FDA decided for it lately?

  • K230590ARDO BellisArdo Medical AG · 2023
  • K212773ARDO AlyssaArdo Medical AG · 2022
  • K172067One Mum PumpsetArdo Medical AG · 2017
  • K150721ARDO Calypso Pro Powered Breast PumpArdo Medical AG · 2015
  • K141742Ardo Carum and Calypso Powered Breast PumpsArdo Medical AG · 2014
  • K011601Ardo Suction Pump Master, Model 30.00.XX; Ardo Suction Pump Senator, Model 31.00.XXArdo Medical AG · 2001

All 6 as Ardo Medical AG →