Atlas FDA

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

HKM · Predicate Candidate Screening

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

35 daysmedian FDA review time
139 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K964338RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISIONRudolf Riester GmbH & Co. KG1997-01-09700
K950791STREAK RETINOSCOPE RX-3Neitz Instruments Company, Ltd.1995-03-28350
K950795STREAK RETINOSCOPE RX-RPNeitz Instruments Company, Ltd.1995-03-28350
K950793SPOT RETINOSCOPE RX-3SPNeitz Instruments Company, Ltd.1995-03-28350
K950794STREAK RETINOSCOPE RX-RCNeitz Instruments Company, Ltd.1995-03-28350
K950792STREAK RETINOSCOPE RX-3ANeitz Instruments Company, Ltd.1995-03-28350
K840840GENERATED RETINAL REFLEX IMAGERY SYSElectro Optical Instruments1984-07-121390

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