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

Pie Data Medical BV — Predicate Candidate Screening

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

279 daysmedian FDA review time

391 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days
K874192	MULTIPURPOSE TRANSDUCER RANGE	Pie Data Medical BV	1988-07-19	279
K870058	PIE MEDICAL SCANNER 1000	Pie Data Medical BV	1988-02-02	391
K870653	ULTRASOUND LINEAR/SECTOR SCANNER 1100	Pie Data Medical BV	1988-02-02	350
K874081	ENTERSCAN	Pie Data Medical BV	1987-12-31	85
K871082	FETAL CARE MONITOR ANTEPARTUM 1500	Pie Data Medical BV	1987-08-04	139

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