Atlas FDA

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

Deltex Medical Limited · Predicate Candidate Screening

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

163 daysmedian FDA review time
405 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K172457Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDeltex Medical Limited2018-06-283180
K150347Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+Deltex Medical Limited2015-07-241630
K142932Deltex Medical KDP72 Doppler ProbeDeltex Medical Limited2015-01-221050
K132139DELTEX MEDICAL CARDIOQ-EDM+Deltex Medical Limited2013-10-10910
K111542DELTEX MEDICAL CARDIOQ EDMDeltex Medical Limited2011-10-201400
K073593I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2Deltex Medical Limited2009-01-294050

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