Atlas FDA

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

Konica Medical Corp. · Predicate Candidate Screening

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

176 daysmedian FDA review time
373 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K990969KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSORKonica Medical Corp.1999-06-18870
K963914CM & CM DS-7Konica Medical Corp.1997-10-083730
K963913MD100 & MM150Konica Medical Corp.1997-10-083730
K955583VIFSKonica Medical Corp.1996-05-141610
K931317KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSORKonica Medical Corp.1993-12-142740
K931315KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSORKonica Medical Corp.1993-12-142740
K931316KONICA DS-7 AUTOMATIC X-RAY FILM PROCESSORKonica Medical Corp.1993-12-142740
K933830KONICA LD-4500 LASER DIGITIZERKonica Medical Corp.1993-12-141310
K931314KONICA QX-70 AUTOMATIC X-RAY FILM PROCESSORKonica Medical Corp.1993-09-071760
K931312KONICA SRX-101 AUTOMATIC X-RAY FILM PROCESSORKonica Medical Corp.1993-09-071760
K931313KONICA QX-130APLUS AUTOMATIC X-RAY FILM PROCESSORKonica Medical Corp.1993-09-071760
K896739KONICA KFDR-SKonica Medical Corp.1990-04-301510

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