Atlas FDA

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

EGN · Predicate Candidate Screening

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

25 daysmedian FDA review time
68 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K932675GXP DENTAL X-RAY PROCESSORGendex Corp.1993-07-26540
K8517201155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORSArtiberia1985-07-02680
K821292TONSIL SCISSORS 7Conphar, Inc.1982-05-28240
K821276MAYO SCISSOR CURYED 5 1/2Conphar, Inc.1982-05-28250
K821294TONSIL SCISSORS STRAIGHT 5 1/2Conphar, Inc.1982-05-28240
K821275MAYO SCISSOR STRAIGHT 5 1/2Conphar, Inc.1982-05-28250
K821077CONPHARConphar, Inc.1982-05-24350

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