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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Ardo Medical AG — Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

112 daysmedian FDA review time
227 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K230590ARDO BellisArdo Medical AG2023-03-30270
K212773ARDO AlyssaArdo Medical AG2022-04-152270
K172067One Mum PumpsetArdo Medical AG2017-11-291450
K150721ARDO Calypso Pro Powered Breast PumpArdo Medical AG2015-06-17900
K141742ARDO CARUM AND CALYPSO POWERED BREAST PUMPSArdo Medical AG2014-10-171120
K011601ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP Ardo Medical AG2001-06-08150

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda