Atlas FDA

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

Planmed OY — Predicate Candidate Screening

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

209 daysmedian FDA review time
409 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250318Planmed XFIPlanmed OY2025-09-262340
K211720Planmed Clarity 2D, Planmed Clarify SPlanmed OY2022-07-184090
K213278Planmed VerityPlanmed OY2022-04-282090
K192317Planmed Clarity 2D and Clarity SPlanmed OY2020-10-234240
K180918Planmed VerityPlanmed OY2018-11-302350
K163328Planmed ClarityPlanmed OY2017-12-283950
K143435Planmed VerityPlanmed OY2015-05-141640
K121418PLANMED VERITYPlanmed OY2013-02-012660
K121963PLANMED NUANCE DIGIGUIDEPlanmed OY2012-11-211390
K042671PLANMED SOPHIE NUANCE CLASSICPlanmed OY2004-11-19510
K021945PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDEPlanmed OY2003-02-212530
K013656PLANMED SOPHIE & PLANMED SOPHIE CLASSICPlanmed OY2002-01-16710
K010116PLANMED SOPHIE, PLANMED SOPHIE CLASSICPlanmed OY2001-03-15580
K991826PLANMED SOPHIE AND SOPHIE CLASSICPlanmed OY1999-08-10740
K983659PLANMED SOPHIE & PLANNED SOPHIE CLASSICPlanmed OY1998-11-16280
K973493PLANMED CYTOGUIDEPlanmed OY1997-11-10560
K962105PLANNED SOPHIED CLASSICPlanmed OY1997-02-052500
K951883PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNITPlanmed OY1995-05-24510
K934373MOBILE SOPHIE MODIFICATIONPlanmed OY1994-04-072110
K923471PLANMED CYTOGUIDEPlanmed OY1992-11-241330

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