Atlas FDA

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

Cooper Medical Devices Corp. · Predicate Candidate Screening

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

35 daysmedian FDA review time
78 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K802927SEBESTYEN IRRIGATING CONTACT LENSCooper Medical Devices Corp.1981-02-05780
K802971LANDERS CONTACT LENSCooper Medical Devices Corp.1981-02-05760
K801850CHARLES PNEUMATIC INTRAOCULAR SCISSORSCooper Medical Devices Corp.1980-09-16430
K801411MAY ILLUMINATED/INFUSION PICCooper Medical Devices Corp.1980-07-21350
K801312THE PROTECTORSCooper Medical Devices Corp.1980-06-17140
K800833VABRA ASPIRATORCooper Medical Devices Corp.1980-05-14300
K791898OCUTOME MODEL 8000Cooper Medical Devices Corp.1979-10-30350

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