Atlas FDA

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

Polaroid Corp. — Predicate Candidate Screening

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

40 daysmedian FDA review time
45 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K812542POLAROID INSTANT ENDOCAMERAPolaroid Corp.1981-10-19450
K812089POLAROID RADIOGRAPHIC FILM CASSETTEPolaroid Corp.1981-08-31400
K812088POLAROID RADIOGRAPHIC FILM PROCESSORPolaroid Corp.1981-08-31400
K811352POLAROID TPX RADIOGRAPHIC FILMPolaroid Corp.1981-06-18350
K792512POLAROID LAND CAMERA FOR ENDOSCOPYPolaroid Corp.1979-12-20150

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