Atlas FDA

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

Orfit Industries NV · Predicate Candidate Screening

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

64 daysmedian FDA review time
100 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K202068The AIO Solution 3.0Orfit Industries NV2020-08-14180
K200282Orfit Aerial CouchtopOrfit Industries NV2020-04-08640
K191158The AIO SolutionOrfit Industries NV2019-08-06970
K171734HP PRO Positioning DeviceOrfit Industries NV2017-07-25430
K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV2016-11-22910
K162862Raycast High Precision Lung Board SolutionOrfit Industries NV2016-11-09280
K151207Proton Immobilization SolutionOrfit Industries NV2015-07-28830
K141787SAGITTILTOrfit Industries NV2014-08-07360
K131795NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALSOrfit Industries NV2013-09-261000

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