Atlas FDA

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

Envision Medical Corp. · Predicate Candidate Screening

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

93 daysmedian FDA review time
137 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K9706053-CCD DIGITAL CAMERAEnvision Medical Corp.1997-05-22930
K953438SURGICAL INTEGRATED CAMERA SYSTEMEnvision Medical Corp.1995-11-061080
K951971XENON LIGHT SOURCEEnvision Medical Corp.1995-05-24270
K944707ISOLATED CAMERA HEADEnvision Medical Corp.1994-10-07140
K934092CAMERA, SURGICAL AND ACCESSORIESEnvision Medical Corp.1994-01-071370

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