Atlas FDA

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

Pie Medical Equipment B.V. · Predicate Candidate Screening

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

213 daysmedian FDA review time
327 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K982203CAAS II LVA BIPLANE OPTIONPie Medical Equipment B.V.1998-07-14220
K945540CAAS IIPie Medical Equipment B.V.1995-06-282260
K915647DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250Pie Medical Equipment B.V.1992-11-093270
K912819SC1150 CW/PDPie Medical Equipment B.V.1992-01-091980
K911584DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480Pie Medical Equipment B.V.1991-10-241990
K911043HEMISPHERE MULTIPLANE ENDORECTAL PROBEPie Medical Equipment B.V.1991-10-092150
K9110447.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1)Pie Medical Equipment B.V.1991-10-072130
K900838TRANSVAGINAL TRANSDUCER ASSEMBLYPie Medical Equipment B.V.1990-05-23900

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